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PHARMACEUTICAL SOCY. OF NEW YORK, INC. v. LEFKOWIT

June 22, 1978

PHARMACEUTICAL SOCIETY OF the STATE OF NEW YORK, INC., Brendan Lawler, Dr. Allan H. Bruckheim, and Marilyn Stuzin, Plaintiffs,
v.
Louis LEFKOWITZ, Albert J. Sica, Gordon M. Ambach, and Robert P. Whalen, Defendants



The opinion of the court was delivered by: BRODERICK

MEMORANDUM ORDER

 VINCENT L. BRODERICK, U.S.D.J.

 An individual pharmacist, a physician, a consumer patient, and the Pharmaceutical Society of the State of New York seek to enjoin the implementation of Chapter 776 of the Laws of 1977 of the State of New York. The challenged statutes, which became effective on April 1, 1978, provide that under certain circumstances pharmacists are to furnish to consumer-patients less expensive drugs which are bioequivalent to those that have been prescribed for them. A hearing on plaintiffs' application for a preliminary injunction was held on April 7, 1978. *fn1"

 I.

 In accordance with the reasoning set forth below, I find that this is an appropriate case to invoke the discretionary doctrine of abstention, and the application for a preliminary injunction is denied. Carey v. Sugar, 425 U.S. 73, 47 L. Ed. 2d 587, 96 S. Ct. 1208 (1976); Railroad Commission of Texas v. Pullman Co., 312 U.S. 496, 85 L. Ed. 971, 61 S. Ct. 643 (1941). The case is placed on the suspense docket pending rulings by the New York State courts on the specific interpretation to be accorded the statutes at issue.

 In 1977 the New York State Legislature passed Chapter 776 of the Laws of 1977 amending the Public Health Law and the Education Law by adding Public Health Law Section 206(1)(o) and Education Law Sections 6810(6) and 6816-a ("the generic drug laws"). *fn2" The purpose of the generic drug laws ostensibly is to make available to consumers cheaper generic drugs in lieu of more expensive brand name drugs which have been prescribed for them by physicians and others authorized by law to write medical prescriptions. The amended law requires the Commissioner of Health of the State of New York to establish and publish a list of drug products approved by the commissioner of the Federal Food and Drug Administration ("FDA") as being safe and effective and which have not been identified by the FDA as having any problem of bioequivalency. Such a list was compiled prior to the effective date of the generic drug laws. Upon reviewing the list, the FDA issued a release advising New York that the State's newly published drug list is "an accurate guide to prescription drugs considered by FDA to be safe, effective and equivalent in therapeutic performance." The FDA further suggested that the list may be useful to other states with similar generic drug laws. *fn3"

 The generic drug laws require that every prescription form contain two lines for the prescriber's signature, one line to read "substitution permissible" and the other line to read "dispense as written." The prescription form must also contain the legend: "This prescription will be filled generically unless physician signs on the line stating 'dispense as written'." If the prescriber approves a substitution he must inform the patient that the pharmacist will substitute a cheaper drug product. N.Y. Education Law § 6810(6) (McKinney 1972).

 Plaintiffs suggest four separate grounds which, they urge, provide legal bases to enjoin the operation of the generic drug laws:

 (1) the federal government has prescribed a comprehensive system of regulation in this area, evincing an intent to preempt regulation by the states under the Supremacy Clause of the Constitution;

 (2) The generic drug laws violate the Commerce Clause of the United States Constitution in that in certain circumstances drugs may not be sold although approved by the FDA as safe and effective;

 (3) The generic drug laws are violative of the Fifth and Fourteenth Amendments to the United States Constitution in various particulars: thus pharmacists are required to sell generic drugs manufactured by companies in which they may not have confidence, and yet the pharmacists must rely on the financial soundness and the adequacy of the insurance protection of those manufacturers for indemnity or contribution in the event of suits; certain groups are illogically excluded from the provisions of the statutes; and implementation of the new law will interfere with the rights of physicians and pharmacists to practice their professions; and

 (4) Implementation of the generic drug laws will constitute an unconstitutional invasion into the rights of privacy of doctors, pharmacists and consumer patients. *fn4" While many of plaintiffs' underlying arguments overlap, I shall discuss the four grounds seriatim, as presented in plaintiffs' papers.

 II.

 Plaintiffs allege that the generic drug laws violate the Supremacy Clause (U.S. Const. Art. VI, cl. 2) in the ...


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