The opinion of the court was delivered by: NEAL P. MCCURN
MEMORANDUM-DECISION AND ORDER
Plaintiffs, nine patients of co-defendant Whitney J. Young, Jr. Health Center, Inc.'s Rehabilitation Clinic ("Whitney Young" or "Clinic"), commenced this action on January 14, 1992 against Whitney Young and some of its Directors and Supervisors.
In their complaint, plaintiffs allege that the Center, in promulgating new policies, violated federal regulations and state statutory, regulatory, and common laws governing plaintiffs' "take-home medication" privileges.
The case is before the court today on plaintiffs' motion for a preliminary injunction, compelling defendants to restore plaintiffs' take-home medication privileges.
The court has considered the parties' written submissions and oral arguments in conjunction with the controlling law. The following constitutes the court's decision on plaintiffs' motion for preliminary injunction.
The plaintiffs are nine recovering heroin addicts. Complaint para. 18. They are deemed "recovering" addicts presumably because they are fighting to control their addictions through medical treatment and counseling. To that end, plaintiffs are enrolled in Whitney Young's Rehabilitation Clinic, located in Albany, New York. Defendant Frank Moore, M.D., is the Medical Director of the Clinic; defendant William Benton is the Clinic's Program Director.
The Clinic provides its opiate-dependant patients with numerous programs designed to foster the patients' recoveries from their addictions. Among the programs are individual and group counseling, referrals to vocational training, support groups, "Narcotics Anonymous" meetings, HIV education, and referrals to patient detoxification and impatient rehabilitation programs. Benton Aff. (1/21/92) para. 5. The Clinic also operates a methadone treatment program for its heroin-addicted patients, among whom are the plaintiffs. Id.; Complaint para. 18. The Clinic's administration of its methadone treatment program vis-a-vis the plaintiffs is at the center of the controversy before the court today.
A. Whitney Young's Methadone Treatment Program
Methadone is a dangerously addictive drug that is used for treatment of heroin addiction. See, e.g. Dorland's Medical Dictionary 1018 (27th ed. 1988). Apparently, methadone treatment entails substitution of methadone addiction for a patient's heroin addiction, followed by treatment of the methadone addiction. Defendant Moore asserts that "numerous studies have concluded that methadone, when properly administered as part of a program, provides a medically safe, relatively inexpensive and effective treatment for opiate addiction." Moore Aff. (1/21/92) para. 17.
Because methadone is so highly addictive, it is subject to misuse and abuse. See, e.g., N.Y. Comp. Codes R. & Regs. ("NYCRR") tit. 14, § 1040.11(a) (1985); Spunt, Hunt, Lipton & Goldsmith, Methadone Diversion: A New Look, J. Drug Issues 569 (Fall 1986).
Consequently, the United States Food and Drug Administration ("FDA") and the New York State Division of Substance Abuse Services ("NYDSAS") have promulgated elaborate regulations governing methadone's medicinal use. See 21 C.F.R. § 291.501 (1991); 14 NYCRR § 1040. Most notably (for purposes of this discussion), the FDA regulations dictate that methadone may be administered only through an FDA-approved "narcotic treatment program." A program must satisfy numerous criteria before receiving FDA approval, e.g. 21 C.F.R. §§ 291.505(a)(6), (b)(2)(1) (1991), and must operate in compliance with intricate FDA regulations. See generally id. § 291.505; see also 14 NYCRR § 1040.2 -.3 (NYDSAS approval requirement). A program's failure to comply with FDA and/or NYDSAS regulations could result in revocation of the program's authority to administer methadone treatment. 21 C.F.R. § 291.505(i)(1); 14 NYCRR § 1010.8 -.10.
B. Plaintiffs' Take-Home Methadone Treatment
One of the FDA rules governing methadone treatment concerns "take-home" treatment. 21 C.F.R. § 291.505(d)(6)(iv) - (vi). NYDSAS has also issued specific regulations governing take-home treatment. 14 NYCRR 1040.11. If all of the criteria for a given patient are satisfied, then a program may administer methadone treatment on a take-home basis, subject to the procedures set forth in the FDA and NYDSAS regulations.
Briefly, the FDA and NYSDSAS procedures require new patients to appear at the Clinic daily for their methadone treatment and examination. As the patient progresses in his treatment, the Clinic may scale back that patient's requirement to appear at the Clinic daily for treatment and examination, by means of "take-home" treatment. Initially, the patient would appear six days per week, and on the sixth day he may "take-home" the appropriate dosage for the seventh day. If the patient shows continued progress, the Clinic may further scale back the patient's requirement to appear, by allowing the patient to take home methadone twice per week, then three times per week, et cetera. If the patient and Clinic satisfy all of the criteria set forth in the regulations, then methadone treatment can ultimately be administered so that a qualified patient need only appear at the Clinic once per week, to take home a week's supply of methadone. All take-home patients must appear at least once per week, however, for a refill and examination. See generally 21 C.F.R. § 291.505(d)(6)(v).
In August, 1991, 78 of the Clinic's 180 methadone patients received treatment on a take-home basis. Benton Aff. para. 38. The plaintiffs were among the 78 patients receiving take-home treatment. Complaint para. 18. Plaintiffs were at various stages of take-home treatment, ranging from two to five Clinic appointments per week for refills and examinations. Since methadone is administered on a daily basis, the take-home arrangement was advantageous to the plaintiffs, many of whom would otherwise face extreme difficulty in reaching the Center to take the drug. Whitney Young's administration of methadone to the plaintiffs was allegedly done in compliance with FDA standards governing the administration of methadone to patients on a take-home basis.
In August, 1991, certain incidents occurred which prompted Whitney Young to review its take-home treatment policies. Most notably, the Clinic was cited by the FDA for deficiencies in its take-home treatment program. This was not the first time that the Clinic was cited for deficiencies. To make matter worse, four of the Clinic's patients were arrested later in that same month, and charged with the sale or possession of controlled substances. Some of the patients/arrestees were charged with possession and/or sale of methadone. According to defendant Benton, "the publicity surrounding these arrests gave rise to many questions from the public as to the operation of the Clinic's methadone maintenance treatment program." Benton Aff. para. 35.
On September 9, 1991, Whitney Young temporarily suspended its take-home program, pending completion of an internal review of its take-home procedures. Consequently, the 78 patients who had been receiving their methadone treatment on a take-home basis had to report to the Clinic daily in order to receive their treatment.
Whitney Young completed its review within one week. The review resulted in the Clinic's enactment of new policies governing take-home procedures. Plaintiffs allege that the new policy lists nineteen circumstances under which the Center will automatically refuse methadone treatment on a take-home basis. See Policy in Complaint exh. "B". Among the circumstances which, according to plaintiffs, mandate automatic suspension of treatment on a take-home basis are:
-evidence/report of illicit drug use;
-outstanding clinic bill;
-unemployed status, unless the patient is involved in education and/or training;
-involvement in current criminal activity;
-failure to comply with treatment recommendations;
-signs of emotional instability, alcohol abuse, or unstable lifestyle.
See id. Also, patients who are also under other prescriptions in addition to methadone are ineligible for take-home ...