Doe v. Axelrod

• Decision Date: 28 April 1988
• Citation: 136 A.D.2d 410,527 N.Y.S.2d 385
• Parties: Jane DOE, Fred B. Charatan, M.D., Joseph A. Garcia, M.D., Vincent J. Moreno, American Home Products Corp., Hoffmann-La Roche, Inc., The Upjohn Company, Abbott Laboratories, and the Medical Society of the State of New York, Plaintiffs-Respondents, v. David AXELROD, M.D., in his capacity as Commissioner of Health of the State of New York, Defendant-Appellant.
• Court: New York Supreme Court — Appellate Division

Page 385

527 N.Y.S.2d 385

136 A.D.2d 410

Jane DOE, Fred B. Charatan, M.D., Joseph A. Garcia, M.D Vincent J. Moreno, American Home Products Corp., Hoffmann-La Roche, Inc., The Upjohn Company, Abbott Laboratories, and the Medical Society of the State of New York, Plaintiffs-Respondents, v. David AXELROD, M.D., in his capacity as Commissioner of Health of the State of New York, Defendant-Appellant.

Supreme Court, Appellate Division First Department.

April 28, 1988.

Leon D. Lazer, of counsel (George G. Nelson and Beth A. Fox with him on the brief; Shea & Gould, New York City, attorneys) for plaintiffs-respondents.

Darren O'Connor, of counsel (Robert Abrams, Atty. Gen., New York City, attorney) for defendant-appellant.

Before KUPFERMAN, J.P., and SULLIVAN, ASCH, MILONAS and ELLERIN, JJ.

ASCH, Justice.

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 regulation 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 non-refillable 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 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.

to fill a prescription for these medications written by a physician in a neighboring State.

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 Commission 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" (Interim Report of the Temporary State Commission to Evaluate the Drug Laws, NY Legis. Doc. No. 10, at 7, Jan 1972, p 7, Record p 474) 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., W.T. Grant Co. v. Srogi, 52 N.Y.2d 496, 517, 438 N.Y.S.2d 761, 420 N.E.2d 953).

These requirements are certainly met here. Enforcement of the regulation will bring about an enormous governmental intrusion into the doctor-patient relationship 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.

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.

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 U.S.C. §§ 801-966) to the fullest extent practicable. It created the same set of classifications (Public Health Law §...