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ROE v. INGRAHAM

August 13, 1975

Richard ROE, an infant by Robert Roe, his parent, et al., Plaintiffs,
v.
Hollis S. INGRAHAM, as Commissioner of the State of New York Health Department, Defendant, George Patient et al., Intervenors



The opinion of the court was delivered by: CARTER

ROBERT L. CARTER, District Judge.

Status of Proceedings

 This challenge to the constitutional validity of the New York Public Health Law, McKinney's Consol.Laws, c. 45, § 3300 et seq., pursuant to which under §§ 3331(6), 3332, subd. 2(a) and 3334(4) all prescriptions containing Schedule II substances must be filed with the Bureau of Controlled Substances, Licensing and Evaluation (BCSLE) in Albany on forms supplied by the state is before us on the merits. Plaintiffs seek to enjoin permanently so much of the statutory provisions under attack as require that the names of recipients of Schedule II drugs prescribed by licensed physicians as medications be filed with the state for computerization.

 Since the history of the litigation has been set out in our prior opinion, reported at 364 F. Supp. 536, where we denied plaintiffs' motion for a preliminary injunction and defendant's motion to dismiss, we will advert only briefly to the background facts. In 1970 a Temporary New York State Commission to Evaluate the Drugs Laws was created. Its function was to recommend whatever modifications in the law were deemed necessary to meet existing problems in respect of drug abuse. In the Commission's Interim Report drugs were grouped into five schedules. Schedule II drugs (which are the concern of this litigation) recognizably have legitimate and worthwhile uses in the treatment of illnesses and disorders. (Id. at P. 13). Among the Schedule II drugs in this category are, e.g., ritalin, codeine, percodan, morphine and hycodan. These drugs are useful in ameliorating pain, in the treatment of epilepsy, narcolepsy, hyperkinesia, schizoaffective disorders, and migraine headaches, but they also have a high potential for abuse. The legislation before us seeks to prohibit Schedule II legitimate drug medications from being diverted to illegal uses by governmental oversight of the prescription, distribution and use of these drugs.

 In our prior opinion we said that "[plaintiffs'] claims . . . raise novel and serious questions with potentially far-reaching consequences as to the permissible reach of the protection afforded by the right of privacy as an independent constitutional guarantee," 364 F. Supp. at 544, and in refusing to dismiss the action we stated that "plaintiffs must be afforded the opportunity to demonstrate that the computerization of names is not necessary for the accomplishment of the state's goals, that the controls developed by the state are inadequate to protect against unauthorized disclosure of the computerized information and that the injury to the plaintiffs resulting from the implementation of this system of centralized filing is sufficiently serious to overcome any competing state interest." Id. at 546-547.

 Findings of Fact

 The evidentiary facts relevant to decision on the merits were presented to us in four forms (1) by stipulated facts, (2) depositions taken on December 4 and 6, 1974, (3) exhibits, and (4) live testimony before the court on December 2, 1974. What follows are our findings of fact.

 Special prescription forms are required for all Schedule II drugs, and such forms are sent to all qualified physicians who order them. The forms are serially numbered. A letter from the Commissioner of Health instructs physicians on how to secure and obtain the forms, and lists some of the Schedule II drugs and their trade names. A physician dispensing a Schedule II drug is required to keep one copy of the prescription and to mail the original and other copy to the BCSLE in Albany. When the physician prescribes but does not dispense the drug himself, he is again required to keep one copy of the form, but gives the original and remaining copy to the patient, who takes them to a pharmacist in order to have the prescription filled. The pharmacist keeps the original and sends the copy to the BCSLE. The prescription form contains the name, address, telephone number and DEA *fn1" (Drug Enforcement Administration) number of the prescribing physician, the date the prescription was issued, the name, age and address of the patient, the name and amount of the drug prescribed, maximum daily dosage, the signature of the physician, the prescription number issued by the pharmacy, the date the prescription was filled, the NDC (National Drug Code) number of the drug, the DEA number of the pharmacy, and the signature of the dispenser.

 The prescription forms are received in the mail room of BCSLE in Albany. Since April 1, 1973, the effective date of the Act, BCSLE has been receiving approximately 100,000 prescription forms per month. The forms are taken unopened to a receiving room where they are opened, coded, put into batches of 100 each and logged. These tasks are performed by approximately nine clerks. The batches are then taken into a "processing room" which is a part of the Office of Electronic Data Processing (OEDP). There the information on the forms is key punched onto a recorder disc and after the disc is filled, the information is put on magnetic tapes, and the disc is erased. The magnetic tapes are kept in drawers of a locked cabinet, but while the information is on the disc recorder, it is not kept under lock.

 Dr. Arthur G. Baker, Associate Commissioner of Health for Community Health Services, has overall responsibility for the Schedule II prescription program. The BCSLE and the Bureau of Narcotic Control (BNC) are under his jurisdiction. BNC, directed by John J. Bellizzi, is empowered to investigate violations of the Public Health law and of Schedule II regulations. There are 14 BNC investigators in New York City and two each in Buffalo, Rochester, Syracuse, White Plains and Albany. Joseph L. Cannizzaro is the BCSLE director, and his agency, in addition to processing, has responsibility for the retention and security of the forms. OEDP, headed by Joseph Bonacci, though a part of the Dept. of Health, apparently is not under Dr. Baker's jurisdiction but is responsible for processing the information contained on the forms onto computers. Approximately thirty-one employees of the Dept. of Health have access to all computerized information developed through the program.

 As of the December, 1974, date of the trial, the program had then been in effective operation for roughly twenty months. The evidence presented by the state discloses that the computerized information is helpful in facilitating the study of the number of prescriptions filled per month by the average physician, and the number dispensed by the pharmacist; it aids in detecting instances of over-prescribing and over-dispensing, in detecting forgeries and counterfeit prescriptions. Thus far the uses derived from having the individual recipient's identity revealed were reported to be: (1) identifying those persons who using their own name go from doctor to doctor to obtain an illicit supply of drugs and (2) uncovering those receiving more than a 30-day supply of Schedule II drugs per month. Two such names have been discovered since the computerized program has been in operation. Both were referred to the BNC for investigation. In one case, the investigation disclosed a bona fide doctor-patient relationship, and in the other the investigation was still open when all evidentiary data was submitted for our consideration.

 Testimony was presented by Joseph Jules Wasserman, who specializes in auditing the security and controls of computer systems, the burden of which was to demonstrate the weaknesses in the security system at the BCSLE and OEDP in the processing, computerizing and storing of the information on the prescription forms. Dr. Jerry Martin Rosenberg, a psychologist, testified that the program had an adverse effect in respect of the doctor-patient relationship and would dissuade individuals who might need Schedule II drugs from undergoing required treatment.

 At the hearing before us Michael Moe and Mary Doe expressed concern that their children, who are being treated with ritalin for hyperkinesia, will be stigmatized because the state will have a long file on their children in a narcotics and dangerous drug context. Mrs. Doe testified that she has taken her child off ritalin; the child is not doing well without the medication, but the alternative she feels is to have him branded for life. Jane Poe testified that she had had encephalitis followed by complications resulting in the loss of all control of the eyes so that they move uncontrollably in one direction or the other -- an affliction called the oculogyric crisis. When she learned that under the new regulation her name was to go on a computer because the amphetamine with which her condition was treated was a Schedule II drug, she believed she would be labeled a drug addict.

 Martha Patient, who suffers from migraine headaches, is treated by a medication containing fiorinal, codeine and cathedot. On learning that her name was to be reported to Albany and put on a computer when prescriptions for her medication were filled, she stopped the medication. Subsequently, however, her headaches returned, and she was forced to resume treatment. She has no confidence that information once put on a computer will remain confidential. George Patient has cancer of the lungs and had three ribs removed. Percodan was prescribed for the pain. When he learned his name would go to Albany, he tried ...


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