Court Opinion

ID: 5901423
Source: CourtListenerOpinion
Date Created: 2022-01-13 03:22:24.17271+00
Date Added: 2024-06-11T08:45:41.189100
License: Public Domain

OPINION OF THE COURT
Asch, J.
The dissent is an extensive legal and medical tract. However, the only issue now before us is the very narrow one of whether Special Term improperly granted a preliminary injunction temporarily restraining the New York State Commissioner of Health from putting the instant regulation into immediate effect, in advance of a trial. Such a trial will provide a broad forum for the expression of expert medical and public health authority on the efficacy of the proposed regulation, instead of what seems to be a rather skewed sample submitted by the Commissioner in support of his project.
We agree with the determination by the Justice at nisi prius that questions as to the legality of the regulation, as well as the impact of its imposition on millions of New York citizens and the practice of medicine, warrant a delay until a final determination is made on the merits.
Plaintiffs are a coalition including a patient, two physicians, a pharmacist, several pharmaceutical manufacturers, and the Medical Society of the State of New York. They brought this action, in June 1987, to declare the Commissioner’s promulgation of this amended regulation unconstitutional and beyond his authority, asserting that such directive constituted an unauthorized exercise of power, was arbitrary and capricious and was not in furtherance of or consistent with the purposes of the Controlled Substances Act. They asserted that the regulation imposed an unacceptable burden on the medical and pharmaceutical professions, that it interfered with medical care of patients by doctors, that it constituted an invasion of privacy, and that it violated the provisions of sections 202-a and 202-b of the State Administrative Procedure Act and the Interstate Commerce Clause of the United States Constitution.
Plaintiffs have raised very substantial medical, as well as legal, issues of constitutional magnitude. They assert that the *413regulation in dispute requires that certain frequently prescribed tranquilizing medications officially known as benzodiazepines be subjected to the strict prescription control reserved for drugs of the greatest abuse, under the provisions of New York’s Controlled Substances Act (Public Health Law §§ 3300-3397). Specifically, the regulation mandates that the physician use a printed prescription form provided by the State; limits the patient to a 30-day nonrefillable supply of the medication; compels the physician to see the patient every month in order for the patient to continue to receive such medication, even if the physician considers such a visit unnecessary; causes the patient’s name, the physician’s name, the pharmacy’s name, and the type, quantity and dosage of the medication to be entered in the State’s computerized drug enforcement records each time such a prescription is issued, thereby showing that the patient is under treatment involving the strictest State drug abuse surveillance; and makes it illegal for a New York pharmacy to fill a prescription for these medications written by a physician in a neighboring State.
At the present time, only the drugs found in Schedule II, which present an extremely high risk for abuse, are required to be prescribed on official New York State prescription forms, of which one copy is retained by the physician, one by the pharmacist and one forwarded to the State for entry in the State’s computer banks. Only a 30-day supply may be prescribed and refills may not be obtained. On the other hand, drugs under a Schedule IV, such as Valium, may be prescribed on ordinary prescription forms, and with certain exceptions may be prescribed only for 30 days, but the prescriptions may be refilled as the physician has indicated.
We concede that the Controlled Substances Act expressly authorizes the Commissioner by rule or regulation to require that Schedule III or IV drugs be prescribed only upon official New York State prescription blanks (Public Health Law § 3338 [3]).
However, plaintiffs argue that while one of the purposes of the statute was to control and prevent the illicit flow and marketing of legal but dangerous drugs, the real and admitted purpose of the Commissioner in promulgating this amended regulation was to inhibit the use and dispensing of these drugs in New York by forcing a 25% reduction in the sale of benzodiazepines. The ulterior motive ascribed to the Commis*414sioner is that, as a result, Medicaid expenditures in this State would be considerably reduced.
The plaintiffs contend, on the other hand, that the primary intent of the Controlled Substances Act was to "stem the flow of dangerous drugs to the illicit market” (Jan. 1972 Interim Report of Temporary State Commn to Evaluate the Drug Laws, 1972 NY Legis Doc No. 10, at 7) rather than to further the personal, social and medical aims of the Commissioner.
Finally, the fact asserted by the Commissioner, that 39 proceedings against health care professionals allegedly have been instituted by the Health Department for the improper handling of benzodiazepines, must be viewed in its proper context. There are over 50,000 physicians in the State and, no doubt, at least as many nurses and pharmacists. The purported illicit diversion of benzodiazepines by 39 health care professionals over an unstated period of time, as the plaintiffs assert, is woefully scant evidence of any serious problem. These statistics are utterly dwarfed by the fact that, according to the Commissioner’s estimate, 8,000,000 benzodiazepine prescriptions were written in New York in 1985 alone. We agree with the plaintiffs that it is amazing that the Commissioner can argue that 39 proceedings covering alleged violations for an unstated number of years can be offered as a rational basis for putting a vast number of people in this State under drug abuse surveillance and interfering with the physician-patient relationship of many millions more in the future.
Thus, the claim by plaintiffs that the New York Commissioner adopted the disputed regulation not to prevent the flow of tranquilizers to the underground market, but rather to curb the prescribing practices of physicians who in good faith are prescribing these medications to their patients, has a prima facie validity. They contend that the proposed rule intrudes upon the physician-patient relationship and is an ill-disguised attempt by the Commissioner to impose his philosophy that tranquilizers are "legitimately” overprescribed, despite the good-faith belief of many medical practitioners that such is not the case.
It is well-established law that, to be granted a preliminary injunction under New York law, the movant must establish a likelihood of success on the merits, irreparable injury absent a granting of the injunction, and a balancing of the equities in its favor (see, e.g., Grant Co. v Srogi, 52 NY2d 496, 517).
These requirements are certainly met here. Enforcement *415of the regulation will bring about an enormous governmental intrusion into the doctor-patient relationship, posing a threat to physicians who in good faith prescribe larger amounts of benzodiazepines than the Commissioner, as a physician, might himself prescribe under similar circumstances. Certainly, the equities favor plaintiffs since they seek only to preserve the status quo pending determination of the issues. No harm will result to the commonweal by reason of a delay of a few months in implementing the regulation, assuming its validity is upheld.
On the other hand, the injuries which will occur at this time if the regulation takes effect will be significant and irremediable. As noted, there will be wholesale intrusions into the confidentiality of the doctor-patient relationship. The State Government will have a computerized record of every person who suffers from anxiety or depression and for whom tranquilizers are prescribed. Many millions of New Yorkers who suffer from psychological maladies will, in effect, have to register this disability in a central governmental registry. Possibly many of them may refuse needed medication for fear of their jobs or reputations.
Many physicians may succumb to their desire to avoid the administrative “red tape”, or the possibility that they may be investigated for their prescribing of tranquilizers, and not prescribe such medication even where its use would help the patient. The old and poor would be seriously affected by the costs and burden of monthly visits to their physicians, so that they will forego needed medicine. Executives, public officials and those similarly situated may well fear the job consequences of having their names on a roster of those using tranquilizers. The equities, therefore, are heavily in favor of continuing the injunctive relief until trial.
Plaintiffs contend that Public Health Law § 3338 (3) is an unconstitutional delegation of legislative power to the Commissioner.
The New York Controlled Substances Act was intended to be and is consistent with the Federal Controlled Substances Act (21 USC §§ 801-966) to the fullest extent practicable. It created the same set of classifications (Public Health Law § 3306). In New York, however, the inclusion of a new pharmaceutical preparation in a particular classification or the change of a classification to a more strictly controlled one was specifically reserved to the State Legislature. On several occa*416sions the Legislature has enacted statutes adding new pharmaceuticals to the schedules (see, L 1986, ch 826; L 1981, ch 474; L 1981, ch 455). In all cases the Legislature has followed the determination of the Federal authorities.
In 1975, after a medical, scientific and administrative review, the benzodiazepines were classified by the Federal controlled substance authorities in Schedule IV. Thereafter, the New York State Legislature included them in Schedule IV under the New York Controlled Substances Act. This classification has been preserved after more recent review of the benzodiazepines.
As recently as 1985, the State Legislature reenacted the schedules to reflect additional drugs, including new benzodiazepines. At that time (consistent with Federal regulation), it included all controlled benzodiazepines in Schedule IV (see, L 1985, ch 664, § 1).
The Federal authorities have not reclassified benzodiazepine products from Schedule IV to Schedule II. The New York State Legislature has not done so either, and benzodiazepine products remain Schedule IV substances under the New York Controlled Substances Act.
The Legislature ostensibly empowered the Commissioner to designate, by rule or regulation, any additional substances listed in Schedules III or IV as being subject to the triplicate requirement and the other restrictive regulations (Public Health Law § 3338 [3]). The Commissioner exercised this authority by amending his Department’s regulations to extend the triplicate prescription requirement over the drugs in Schedule IV known as benzodiazepines.
Whether the Legislature actually contemplated that the Commissioner would actually extend the sweep of the regulations governing the prescription and use of the most dangerous drugs to tranquilizers, and whether the Legislature contemplated that the millions of users, prescribers and dispensers would be enrolled upon a State roster, raises a question of legislative intent which should be explored. Finally, if the Legislature so intended, as the short history of this statute shows, the plaintiffs have raised a real issue of whether this was a proper delegation of legislative authority.
What this court must decide is whether the Commissioner’s fiat requiring registry of tranquilizer prescriptions should go into immediate effect without a trial, despite the fact that large segments of the medical profession profoundly disagree *417with the effort to transform a statute enacted to restrict illicit diversion of drugs into a statute that imposes upon the medical profession the Commissioner’s view as to how and how often tranquilizers should be prescribed to those who need them.
The recent case of Boreali v Axelrod (71 NY2d 1) gives much support for the view expressed here that the regulation should be subjected to comprehensive legal scrutiny at a trial, rather than adopted in the summary fashion sought by the respondents. In Boreali (supra), the Court of Appeals struck down regulations proposed by the Commissioner of Health when his Public Health Council promulgated a code to govern tobacco smoking in areas that are open to the public.
The court, in the opening paragraph of its opinion, forthrightly set forth the essential basis for its decision: "We hold that the Public Health Council overstepped the boundaries of its lawfully delegated authority when it promulgated a comprehensive code to govern tobacco smoking in areas that are open to the public. While the Legislature has given the Council broad authority to promulgate regulations on matters concerning the public health, the scope of the Council’s authority under its enabling statute must be deemed limited by its role as an administrative, rather than a legislative, body. In this instance, the Council usurped the latter role and thereby exceeded its legislative mandate, when, following the Legislature’s inability to reach an acceptable balance, the Council weighed the concerns of nonsmokers, smokers, affected businesses and the general public and, without any legislative guidance, reached its own conclusions about the proper accommodation among those competing interests. In view of the political, social and economic, rather than technical, focus of the resulting regulatory scheme, we conclude that the Council’s actions were ultra vires and that the order and judgment of the courts below, which declared the Council’s regulations invalid, should be affirmed.” (Boreali v Axelrod, supra, at 6.)
Likewise, in this case, plaintiffs have set forth at least a prima facie showing that the Commissioner promulgated this regulation imposing the various restrictions on the tranquilizers not because of purely health considerations within his province, but because of social and economic (if not also political) considerations which are solely within the Legislature’s province.
*418The Appellate Division, in that case, as cited by the Court of Appeals, noted that the challenged smoking regulation " 'effectuate[d] a profound change in social and economic policy’ and that the agency had obviously based the details of its regulatory scheme as much on concerns about 'economic impact’ as on considerations of public health” (Boreali v Axelrod, supra, at 8).
In his discussion of separation of powers as applied to the Boreali smoking code, Judge Titone, writing for the majority, explained (supra, at 9-11):
"However facially broad, a legislative grant of authority must be construed, whenever possible, so that it is no broader than that which the separation of powers doctrine permits (see, Tribe, American Constitutional Law § 5-17, at 288-289). Even under the broadest and most open-ended of statutory mandates, an administrative agency may not use its authority as a license to correct whatever societal evils it perceives (see, e.g., Matter of Council for Owner Occupied Hous. v Abrams, 125 AD2d 10). Here, we cannot say that the broad enabling statute in issue is itself an unconstitutional delegation of legislative authority. However, we do conclude that the agency stretched that statute beyond its constitutionally valid reach when it used the statute as a basis for drafting a code embodying its own assessment of what public policy ought to be * * *
"A number of coalescing circumstances that are present in this case persuade us that the difficult-to-define line between administrative rule-making and legislative policy-making has been transgressed. While none of these circumstances, standing alone, is sufficient to warrant the conclusion that the PHC has usurped the Legislature’s prerogative, all of these circumstances, when viewed in combination, paint a portrait of an agency that has improperly assumed for itself '[t]he open-ended discretion to choose ends’ (Tribe, op. cit., at 285), which characterizes the elected Legislature’s role in our system of government.”
Plaintiffs have made enough of a showing on the motion before us to establish a likelihood of success in their contention that the Commissioner acted in excess of his powers, even though those powers delegated to the Commissioner are very broad. "Striking the proper balance among health concerns, cost and privacy interests, however, is a uniquely legislative function” (Boreali v Axelrod, supra, at 12).
*419As the nisi prius court concluded, these issues are of such serious import that this regulation should not become effective without exploration of them and their ramifications. Vast numbers of New Yorkers are entitled to the protection of an adversarial test of the propriety and constitutionality of this contested regulation. "Here, plaintiffs predicate their right to ultimate relief upon an argument that * * * may not prove to be ultimately successful, but it is based on substantial principles of constitutional law and involves novel issues of first impression * * * This is precisely the situation in which a preliminary injunction should be granted to hold the parties in status quo while the legal issues are determined in a deliberate and judicious manner (see, especially, New York Life Ins. Co. v Pink, 77 NYS 2d 612, 613; Coler v American Soc. for Prevention of Cruelty to Animals, 122 NYS 549, 550-551; cf. Borden’s Co. v Baldwin, 293 US 194, 213; cf. Matter of Schwartz v Rockefeller, 38 AD2d 995, 996 [Cooke, J., concurring], app dsmd 30 NY2d 664). In view of the conceded irreparable harm facing plaintiffs as contrasted with the damage the State would face by postponing implementation of the statute until this case can be heard on its merits, Special Term properly exercised its discretion by granting plaintiffs’ motion for a preliminary injunction (New York Life Ins. Co. v Pink, supra, p 613).” (Tucker v Toia, 54 AD2d 322, 326.)
We agree, however, with the procedural conclusion of the dissent that the nisi prius court erred in converting these actions into a CPLR article 78 proceeding.
Accordingly, the order of the Supreme Court, New York County (Edith Miller, J.), entered on December 3, 1987, which sua sponte converted the instant declaratory judgment action into a proceeding pursuant to CPLR article 78 and granted plaintiffs’ application for a preliminary injunction, should be modified, on the law, to restore the matter to a declaratory judgment action, and otherwise affirmed, without costs or disbursements.