Rehabilitation Act of 1974, codified at 29 U.S.C. § 794 (West Supp. 1991) (the "Act"), as for plaintiffs Belser, Howard, Allegra, Krzemenski, and Gamari, and (2) FDA regulations governing administration of methadone treatment, codified at 29 C.F.R. § 291.505 (1991).
Plaintiffs' mere statement of a federal cause of action is not necessarily enough to invoke this court's jurisdiction through § 1331. The Supreme Court has instructed that the inquiry into subject matter jurisdiction does not end with the presence of a claim purporting to arise under federal law. As this court noted in McRae, "[a] claim that is purportedly based upon federal law should nonetheless be dismissed for want of subject matter jurisdiction if it is 'so insubstantial, implausible, foreclosed by prior decisions of this Court, or otherwise completely devoid of merit as not to involve a federal controversy within the jurisdiction of the District Court . . . .'" McRae, 1991 WL 274261 (quoting Oneida Indian Nation of New York v. County of Oneida, 414 U.S. 661, 666, 39 L. Ed. 2d 73, 94 S. Ct. 772 (1974)). See Town of West Hartford v. Operation Rescue, 915 F.2d 92, 100 (2d Cir. 1990); Giulini v. Blessing, 654 F.2d 189, 192 (2d Cir. 1981) ("For jurisdictional purposes, the test is whether the complaint on its face, without resort to extraneous matter, is so plainly insubstantial as to be devoid of any merits and thus not presenting any issue worthy of adjudication"). This court takes the Oneida Indian Nation and Giulini standards to mean, at minimum, that a federal claim should be dismissed if it is obvious from the face of the complaint that plaintiff would not be able to withstand an imminent motion to dismiss pursuant to Fed. R. Civ. P. 12(b).
Defendants argue that plaintiffs' purported federal causes of action herein fall into the category of being so "devoid of merit" that they do not actually confer subject matter jurisdiction upon the court. The bases for defendants' argument are two-fold. With respect to plaintiffs' Rehabilitation Act claims, defendants argue that plaintiffs have not stated a claim upon which relief can be granted. With respect to plaintiffs' causes of action under the FDA regulations, defendants contend that plaintiffs cannot maintain a suit thereunder because the regulations are administrative in nature, and therefore do not allow for a private cause of action.
In so arguing, defendants have presented a serious challenge to this court's authority to consider plaintiffs' motion for a preliminary injunction. Therefore, the court must carefully consider whether plaintiffs' federal causes of action are sufficient to confer subject matter jurisdiction upon the court.
1. Plaintiffs' claims under the Rehabilitation Act of 1974.
In their third cause of action, plaintiffs Belser, Howard, Allegra, Krzemenski, and Gamari allege that the Clinic's decision to terminate their take-home methadone treatment violates section 504 of the Act, 29 U.S.C. § 794. Section 504 states, in pertinent part, that "no otherwise qualified individual with handicaps in the United States . . . shall, solely by reason of her or his handicap, be excluded from participation in, be denied benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance . . . . " 29 U.S.C. § 794 (West Supp. 1991).
Even if the five plaintiffs asserting this cause of action are handicapped within the meaning of the § 504,
plaintiffs still run into an insurmountable barrier in pursuing this cause of action. Plaintiffs' trouble stems from the fact that the Act only prohibits discrimination that is based solely on the basis of handicap. See id. That is to say, if plaintiffs allege discrimination on a basis which turns on characteristics other than handicap, then they have not stated a cause of action recoverable under § 504 of the Act. Although there is surprisingly little case law exploring this element in any detail, those courts having spoken on the issue have ruled that a plaintiff cannot prevail on a claim brought under the Act without showing that his handicap was the sole basis for the alleged discrimination. See Norcross v. Sneed, 755 F.2d 113, 117 n.5 (8th Cir. 1985); Lunceford v. District of Columbia Bd. of Educ., 241 App. D.C. 1, 745 F.2d 1577, 1580 (D.C. Cir. 1984); Bernard B. v. Blue Cross and Blue Shield of Greater New York, 528 F. Supp. 125, 132 (S.D.N.Y. 1981), aff'd, 679 F.2d 7 (2d Cir. 1982); see also Assa'ad-Faltas v. Commonwealth of Virginia, 738 F. Supp. 982, 987 (E.D. Va.), aff'd mem., 902 F.2d 1564 (4th Cir. 1990).
Contrary to their counsel's suggestion at oral argument, it is plain from the face of their complaint that plaintiffs have not alleged that their handicap condition formed the sole basis for the Clinic's decision to revoke their take-home treatment privileges. Rather, through their Complaint, specifically paras. 38-39, 46-47, 83 & exh. "B", plaintiffs allege that their take-home privileges were terminated because they are unemployed, and that they are unemployed because they are handicapped. Plaintiffs' concession that their unemployed status was a determinative factor in the Clinic's alleged discriminatory treatment of them is fatal to their case. Once plaintiffs alleged that another factor, their unemployed status, formed the basis of the Clinic's decision to terminate their take-home treatment, plaintiffs could no longer argue that their handicap formed the sole basis for the Clinic's alleged discriminatory treatment.
To better illustrate why plaintiffs' Rehabilitation Act claim is flawed, the court notes plaintiffs' allegation that the Clinic's policy at issue lists unemployment, but not handicap, as a circumstance mandating revocation of take-home methadone treatment. See Complaint exh. "B". It is entirely possible, therefore, that a handicapped patient can receive methadone treatment on a take-home basis, so long as the handicapped individual is also employed and meets all of the other eligibility requirements. Since, under the allegations set forth in plaintiffs' complaint, handicapped patients may be entitled to methadone treatment on a take-home basis, plaintiffs cannot logically contend that the Clinic discriminates solely on the basis of handicap.
It is clear from plaintiffs' complaint that the Clinic discontinued their take-home treatment because plaintiffs were unemployed. The Clinic's decision in this respect may have been unfair; it may even have been negligent. Those issues are not now before this court. For purposes of this discussion, the court is compelled to conclude that the Clinic did not discriminate, or otherwise deprive plaintiffs of certain benefits, solely on the basis of plaintiffs' handicap. Therefore, plaintiffs have not stated a claim under the Act upon which relief can be granted. See 29 U.S.C. § 794; Fed. R. Civ. P. 12(b)(6).
2. Plaintiffs' claims under the FDA regulations.
In light of the foregoing discussion, plaintiffs' only remaining basis for invoking federal court jurisdiction rests in their claims that defendants violated several requirements of the FDA regulations. In a nutshell, plaintiffs allege that the Clinic acted unreasonably in enacting the new take-home policy and failed to make treatment decisions based upon individualized medical judgment, in violation of numerous sections of the regulations.
Without conceding to having violated any of the FDA regulations, defendants contend that plaintiffs have not stated a claim upon which relief can be granted. Specifically, defendants allege that the FDA regulations cited by plaintiff are regulatory, or administrative, in nature, and as such are not meant to provide the basis of a right to assert a private cause of action for violations thereof. Since the FDA regulations do not allow for a private cause of action, argue defendants, plaintiffs cannot maintain this suit thereunder.
Defendants correctly assert that not all laws allow for a private right of action. The Supreme Court has written that "the fact that a federal statute has been violated and some person harmed does not automatically give rise to a private cause of action in favor of that person." Cannon v. University of Chicago, 441 U.S. 677, 688, 60 L. Ed. 2d 560, 99 S. Ct. 1946 (1979), quoted in, e.g., Touche Ross & Co. v. Redington, 442 U.S. 560, 568, 61 L. Ed. 2d 82, 99 S. Ct. 2479 (1979). Rather, the right of a private citizen (as opposed to just an administrative agency) to bring suit under a given statute must be either specifically created in the statute, or else implied from the terms of the statute. E.g. id.; Siebert v. Conservative Party of New York State, 724 F.2d 334, 337 (2d Cir. 1983), cert. denied, 466 U.S. 980, 80 L. Ed. 2d 835, 104 S. Ct. 2363 (1984).
At oral argument, plaintiffs' counsel readily acknowledged that neither the FDA regulations nor the regulations' enabling legislation expressly creates a private cause of action for violations. Therefore, the court is left to determine whether the regulations implicitly create a private cause of action.
Whether a private cause of action exists depends entirely on whether Congress intended to create a private remedy. Transamerica Mortgage Advisors, Inc. v. Lewis, 444 U.S. 11, 16, 62 L. Ed. 2d 146, 100 S. Ct. 242 (1979); California v. Sierra Club, 451 U.S. 287, 293, 68 L. Ed. 2d 101, 101 S. Ct. 1775 (1981); Pryor v. United States Steel Corp., 794 F.2d 52, 57 (2d Cir.), cert. denied, 479 U.S. 954, 93 L. Ed. 2d 393, 107 S. Ct. 445 (1986). In Cort v. Ash, 422 U.S. 66, 78, 45 L. Ed. 2d 26, 95 S. Ct. 2080 (1975), the Supreme Court identified four factors which are relevant to consideration of Congressional intent.
It is important, however, that the court not be weighed down in the Cort factors. "While [the Cort] factors remain relevant, the central inquiry must be whether Congress intended to create a private cause of action." Bennett v. United States Trust Co. of New York, 770 F.2d 308, 311 (2d Cir. 1985), cert. denied, 474 U.S. 1058, 88 L. Ed. 2d 776, 106 S. Ct. 800 (1986); see Pryor, 794 F.2d at 57 ("'the Supreme Court [has] compressed the Cort test to a consideration solely of legislative intent'") (citation omitted). Thus, the court must attempt to discern whether Congress intended to create a private cause of action under the FDA regulations.
For the reasons discussed infra, the court can comfortably conclude that neither Congress nor the FDA intended to benefit methadone patients, such as the plaintiffs, when they promulgated the current FDA regulations. That is to say, the regulations were not intended for the "especial benefit" of the plaintiffs. See Cort, 422 U.S. at 78. The fact that the regulations were not enacted for these plaintiffs' benefit is probative of Congress's intent because is indicates that Congress did not intend for this class of plaintiffs to be protected by the regulations. The argument runs that if Congress did not intend for these plaintiffs to be protected by the regulations, then Congress did not intend to allow plaintiffs to sue to enforce the regulations' terms. See, e.g., Sierra Club, 451 U.S. at 293; Pryor, 794 F.2d at 57; Siebert, 724 F.2d at 337.
Congress's (and the FDA's) intent in this respect is apparent from the purpose of the regulations. The FDA regulations were designed to protect the general public from the misuse and abuse of methadone that can occur with the legalized use of such a highly addictive drug. The purpose behind the FDA regulations, in other words, centers on drug prevention and enforcement, and not medical treatment for recovering addicts. To be sure, the regulations state that they were enacted in response to concerns about the "number of dangers and possible abuses [which] may arise from [use of methadone as a treatment for prolonged narcotic dependence] if professional services and controls are inadequately applied." 21 C.F.R. § 291.501(a). Since the regulations were not intended to benefit the plaintiffs, plaintiffs' suit to enforce the terms-- and presumably to benefit therefrom-- seems contrary to Congressional intent.
The legislative history behind the enabling legislation supports the view that the FDA regulations were enacted to benefit (and protect) the general public, as opposed to this class of plaintiffs. The parties do not agree on exactly which statute is the enabling legislation for the FDA regulations. The Second Circuit resolved the dispute, however, in Luna v. Harris, 888 F.2d 949, 953-54 (2d Cir. 1989). The enabling legislation, according to Luna, actually consists of two Congressional acts: the Comprehensive Drug Abuse Prevention and Control Act, 42 U.S.C. § 257a (1982) ("the 1970 Act"), and the Narcotic Addict Treatment Act of 1974, 21 U.S.C. § 823(g) (1982) (the "1974 Act"). Luna, 888 F.2d at 953 ("Pursuant to this authority, the FDA . . . has promulgated regulatory guidelines for the establishment and operation of methadone treatment programs for narcotics addicts") (citing the FDA regulations). In fact, the regulations explicitly state that the conditions set forth therein for the administration of methadone treatment are promulgated pursuant to section 4 of the Comprehensive Drug Abuse Prevention Act of 1970. 21 C.F.R. § 291.505.
The legislative history of the 1970 Act states that the purpose of that Act is to promote "increased efforts in drug abuse prevention and rehabilitation," "more effective means for law enforcement aspects of drug abuse prevention and control," and "an overall balanced scheme of criminal penalties for offenses involving drugs." H.R. Rep. No. 91-1444, 91st Cong., 2d Sess. 1444, reprinted in 1970 U.S. Code Cong. & Admin. News 4566, 4567, quoted in Def. Supp. Brief (1/23/92), at 2. In Luna, the Second Circuit provided insight into the interplay between the 1970 Act and its "supplement", the 1974 Act, when it wrote:
The passage of the 1970 Act resulted in a substantial increase in the number of methadone treatment clinics nationwide. As a result, the risk of illegal diversion of methadone increased. The 1974 Act was passed primarily to respond to this problem. Its chief purpose was "to curb the diversion and abuse of narcotic drugs used in the treatment of narcotic addicts." Congress found that "the use of methadone in the treatment of heroin addiction involves unique and unusually great risks of diversion and criminal profiteering," and noted that a frequent source of illicit methadone was diversion by addicts abusing take-home privileges. The 1974 Act was accordingly designed to "permit flexibility in treatment, while requiring adequate accountability for narcotic drugs administered in that treatment. It . . . provides a statutory complement to the FDA regulations, and provides more specific controls over diversion."
Id. at 954 (citations omitted).
The effect of the legislative history behind these enabling statutes was the promulgation of the FDA regulations. Pursuant to their objectives, the regulations recognize that methadone use has shown promise in the treatment of narcotic addictions, but also recognize the need to protect the general public from the dangers of legalized methadone use. 29 C.F.R. § 291.501(a), (b).
In accordance with their objectives, the regulations are restrictive, not expansive, in nature with respect to administration of methadone treatment. In other words, the regulations limit the extent to which methadone treatment can be administered. The most pertinent example of the restrictive nature of the regulations is found in the provision governing take-home medication, wherein the regulations state, "take-home medication may be given only to a patient who, in the reasonable judgment of the program physician, is responsible in handling narcotic drugs." 29 C.F.R. § 291.505(d)(6)(iv)(A) (emphasis added). That same provision limits the ability of a Clinic to administer methadone treatment on a take-home basis in several other respects, as well. See id. See also, e.g., 29 C.F.R. § 291.505(b)(2)(i) ("before a narcotic treatment program may be lawfully operated, the program . . . shall submit [certain applications] and must receive approval . . . . "); id. § 291.505(b)(2)(iv) (program must be approved before administering methadone); id. § 291.505(b)(3)(v) (program must be administered in accordance with regulations). All of these restrictions on methadone distribution corroborate the notion that the regulations are intended to benefit not the plaintiffs but the general public, by protecting it from the trouble inherent with treating heroin addiction with methadone.
The finding that the FDA regulations were not intended to benefit these plaintiffs is buttressed by the fact that the regulations do not create a right in the plaintiffs to receive methadone. The regulations explicitly state as much in the provision governing gradual implementation of take-home treatment:
(v) Take-home requirements. The requirement of time in treatment is a minimum reference point after which a patient may be eligible for take-home privileges. The time reference is not intended to mean that a patient in treatment for a particular time has a specific right to take-home medication. Thus, regardless of time in treatment, a program physician may, in his or her reasonable judgment, deny or rescind the take-home medication of a patient.
21 C.F.R. § 291.505(d)(6)(v) (emphasis in original of heading; emphasis added to text). See Transamerica Mortgage Advisors, Inc., 444 U.S. at 16 (court must afford substantial weight to the express terms of the regulations); Touche Ross & Co., 442 U.S. at 568 (same). If plaintiffs do not have a right to receive take-home methadone treatment, it is difficult to imagine how they can argue that they have a right to sue to receive take-home methadone treatment. The argument is contrary to the express terms of the regulation.
The provision stating that "a program physician may, in his or her reasonable judgment, deny or rescind the take-home privileges of a patient," 29 C.F.R. § 291.505(d)(6)(v), is telling in this respect, as well. The fact that a doctor has virtually unfettered discretion-- so long as he or she acts reasonably-- to terminate a patient's take-home treatment precludes any argument that a patient has a right to have the doctor administer methadone to him on a take-home basis. The reality is that plaintiffs can point to no language in the regulations providing even an insinuation that a patient is entitled to methadone treatment at all, let alone on a take-home basis.
Given the broad discretion afforded to the program physician to terminate take-home treatment, plaintiffs cannot reasonably argue that they have a right to take methadone on a take-home basis. That the regulation does not create a right to take-home treatment lends credence to the conclusion that the regulation was not intended for the especial benefit of these plaintiffs. And, as stated at numerous points supra, if the regulations were not intended for the especial benefit of the plaintiffs, then the court can assume that Congress did not intend to allow these plaintiffs to benefit from the regulations through a lawsuit.
Finally, the court is persuaded that the "Sanctions" provision of the regulations exhibits the FDA's intent to preclude a private right of enforcement. In 21 C.F.R. § 291.505(i), the regulations set forth four sanctions which might be imposed against the Clinic in the event that the Clinic fails to abide by all of the requirements of the regulations.
The available sanctions include revocation of FDA approval, seizure of drug supplies, injunction, and criminal prosecution. Id. Conspicuously absent from this list is a threat of "civil action" or the like. The FDA's refusal to include "civil action" as an enforcement mechanism is significant when considered in light of the presence of alternative enforcement schemes. The Supreme Court articulated this axiom, albeit in the context of a purported § 1983 action, when it wrote: "when the remedial devices provided in a particular Act are sufficiently comprehensive, they may suffice to demonstrate congressional intent to preclude the remedy of suits under § 1983." Middlesex Cty. Sewerage Auth. v. National Sea Clammers, 453 U.S. 1, 20, 69 L. Ed. 2d 435, 101 S. Ct. 2615 (1981).
Neither the FDA regulations nor their enabling legislation provide any suggestion that Congress intended to create a private cause of action for enforcement of the regulations' terms. This in itself is telling. See Middlesex, 453 U.S. at 20. The inference to be drawn from all of the foregoing circumstances is that the plaintiffs are not the intended beneficiaries of the FDA regulations. As such, they are not entitled to sue to enforce the regulations' terms. Any other conclusion, in this court's view, would be contrary to Congress's intent not to allow a private right of action under the regulations.
This court does not have subject matter jurisdiction to adjudicate over plaintiffs' complaint. Accordingly, plaintiffs complaint must be dismissed, pursuant to Fed. R. Civ. P. 12(b)(2), for want of subject matter jurisdiction. In light of the dismissal, plaintiffs' motion for a preliminary injunction must be denied.
IT IS SO ORDERED.
DATED: January 28, 1992
Neal P. McCurn