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RIZZO v. UNITED STATES

April 7, 1977.

Joseph RIZZO, a/k/a Giuseppe Rizzo, Plaintiff,
v.
UNITED STATES of America and Joseph A. Califano, Secretary of Health, Education and Welfare, Defendants.



The opinion of the court was delivered by: COSTANTINO

COSTANTINO, District Judge.

This action was commenced by an order to show cause requesting injunctive relief.

 Plaintiff is dying from cancer of the pancreas. His physician has testified that this cancer is not susceptible to any treatment available in the United States and that in his estimation plaintiff has three to four months to live. As a result plaintiff wishes to have his physician administer to him a substance known as B17/Laetrile (hereinafter Laetrile). Laetrile is apparently used widely in Mexico as well as twenty five other countries in the treatment of cancer. See Rutherford v. United States, 399 F. Supp. 1208, 1210 (W.D.Okl.), aff'd, 542 F.2d 1137 (10th Cir. 1976). Laetrile, however, is not available in the United States, as a result of its classification by the Food and Drug Administration (hereinafter FDA) as a "new drug" pursuant to 21 U.S.C. § 321(p)(1). Under the provisions of 21 U.S.C. § 355(a) a "new drug" cannot be transported in interstate commerce unless the FDA has approved an application therefor. Apparently no application for approval has yet been filed.

 Plaintiff is therefore seeking an injunction prohibiting the FDA from preventing plaintiff's importation or interstate transportation of Laetrile for purposes of his own consumption. To succeed in his motion for a preliminary injunction plaintiff must demonstrate possible irreparable injury and (1) either likelihood of success on the law and facts then available, or (2) serious questions on the merits making them fair grounds for litigation, as well as a balance of the equities weighing decidedly in favor of preliminary injunctive relief. Sonesta Int'l Hotels Corp. v. Wellington Associates, 483 F.2d 247 (2d Cir. 1973); Triebwasser & Katz v. American Tel. & Tel. Co., 535 F.2d 1356 (2d Cir. 1976).

 The second prong of the test provides an appropriate basis for the resolution of the preliminary injunction question presented in this case. Therefore, plaintiff is entitled to the relief sought if (1) he has presented serious questions going to the merits making them fair grounds for litigation, (2) a balance of the equities tips decidedly in favor of injunctive relief, and (3) if he will suffer possible irreparable injury if injunctive relief is not granted. *fn1"

 The court's function at this stage is therefore limited to an examination of these three issues; it is not necessary, and certainly not appropriate at this stage of the proceedings to make a final determination of the merits.

 I. HAS PLAINTIFF RAISED SUFFICIENTLY SERIOUS QUESTIONS GOING TO THE MERITS TO MAKE THEM FAIR GROUNDS FOR LITIGATION?

 Plaintiff's challenge to the ban on Laetrile is based upon statutory as well as constitutional grounds.

 A. Statutory Grounds

 The statutory objection relates to the alleged failure of the FDA to develop a record in support of its classification of Laetrile as a "new drug." That this argument raises serious questions on the merits making them fair grounds for litigation is illustrated by the decision of the United States Court of Appeals for the 10th Circuit in Rutherford v. United States, 542 F.2d 1137 (10th Cir. 1976). The court in Rutherford noted that an examination of the record developed by the FDA in support of its classification, revealed that

 [There] remain some questions to be determined. These are:

 (1) Was Laetrile marketed on October 9, 1962, as a cancer drug and was it then generally recognized as "safe?"

 (2) Was Laetrile recognized or used as a cancer drug under the same conditions of present use during the period when the Food and Drugs Act of 1906 was in effect, June 30, 1906 to June 25, 1938?

 If the answer to either of these is "yes," Laetrile would be exempt as a "new drug" under the Food, Drug and Cosmetic Act. We regard these questions as ...


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