Breitmeyer v. Califano

• Decision Date: 28 September 1978
• Docket Number: Civ. A. No. 7-72854.
• Parties: Howard H. BREITMEYER et al., Plaintiffs, v. Joseph CALIFANO, Secretary of U. S. Department of Health, Education & Welfare, Defendant.
• Court: U.S. District Court — Western District of Michigan

463 F. Supp. 810

Howard H. BREITMEYER et al., Plaintiffs, v. Joseph CALIFANO, Secretary of U. S. Department of Health, Education & Welfare, Defendant.

Civ. A. No. 7-72854.

United States District Court, E. D. Michigan, S. D.

September 28, 1978.

James E. Wells, Southfield, Mich., for plaintiffs.

L. Michael Wicks, Asst. U. S. Atty., Detroit, Mich., for defendant.

MEMORANDUM OPINION AND ORDER GRANTING DEFENDANT'S MOTION TO DISMISS AND DENYING PLAINTIFFS' MOTION FOR PRELIMINARY INJUNCTION

PHILIP PRATT, District Judge.

Plaintiffs are a group of terminally ill cancer patients and spouses of terminally ill cancer patients. They desire to import into the United States for their own use a substance known as "Essiac", but allege that their efforts toward this end have been thwarted by the policies and actions of the Food and Drug Administration, an agency of the United States Department of Health, Education and Welfare, of which defendant Joseph Califano is the Secretary. On December 5, 1977 they filed their Complaint, seeking, on behalf of all terminally ill cancer patients in southeastern Michigan,¹ a decree declaring that Essiac is exempt from regulation as a new drug under the Federal Food, Drug, and Cosmetic Act of 1938, 21 U.S.C. § 301 et seq., and an injunction prohibiting the FDA from interfering with the importation and use of Essiac by plaintiffs and the putative class.

The matter was first brought before the Court upon the plaintiffs' Motion for Preliminary Injunction. The defendant responded to plaintiffs' Motion with his own Motion to Dismiss. Oral arguments directed to both motions were heard on June 26, 1978. Plaintiffs were given an opportunity to respond in writing to defendant's Motion, and counsel for both sides have agreed to waive further argument.

One of the grounds on which the defendant has premised his Motion is that the Court is without jurisdiction to consider plaintiffs' case and order the relief requested. Within the constitutional framework of our governmental system federal courts have but limited jurisdiction. Article III of the Constitution grants the courts power to hear a case only as Congress chooses to confer such power upon them. Thus, federal courts are charged with the Constitutional duty of constant vigilance and conscientious solicitude for the limits of their jurisdiction. It follows that the Court herein may not properly proceed to consider the merits either of plaintiffs' claim or of defendant's defenses until it has disposed of the jurisdictional question. Bell v. Hood, 327 U.S. 678, 66 S.Ct. 773, 90 L.Ed. 939 (1946).

The Court holds that under the state of facts that have been set forth before it, it lacks the power to order the relief requested in the Complaint and will continue to lack that power until plaintiffs have exhausted the remedies available to them before the FDA.²

To account for this holding, the Court must discuss the pertinent portions of the statutory scheme created by the Food, Drug, and Cosmetic Act, supra, as they have been expounded by the United States Supreme Court and the Sixth Circuit Court of Appeals.

Section 304(a)(1) of the Act, 21 U.S.C. § 334(a)(1), subjects to liability for seizure and condemnation any drug whose introduction into interstate commerce is prohibited by Section 505. Section 505(a) of the Act, 21 U.S.C. § 355(a), prohibits the introduction or delivery for introduction into interstate commerce of any new drug, unless a new drug application that conforms to the standards prescribed in Section 505(b) has been filed with the FDA and has been approved. "New drug" is a term of art, defined in Section 201(p)(1), 21 U.S.C. § 321(p)(1), to encompass

"any drug . . . the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof, . . ."

but excluding from the class so defined any drug

"if at any time prior to the enactment of this chapter i. e., any time before June 25, 1938 it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use; . . ."

This latter provision is commonly referred to as the "1938 grandfather clause."³ Finally, the term "drug" is defined in Section 201(g)(1), 21 U.S.C. § 321(g)(1) to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals."

Plaintiffs concede that under the subjective standards contained in Section 201(g)(1), Essiac is a drug; it is intended to be used as a remedy for cancer, or at least as a palliative, and in light of such intended use, it is encompassed in the broad statutory definition. See U. S. v. Bacto-Unidisk, 394 U.S. 784, 89 S.Ct. 1410, 22 L.Ed.2d 726 (1969). Their position is that regardless of the opinion of qualified experts as to the safety and effectiveness of Essiac, it falls within the purview of the 1938 grandfather clause and, therefore, is not a new drug, as defined by § 201(p)(1), with the result that it is exempt from the new drug application requirements of § 505. The defendant contends that the Court would exceed its authority if it, rather than the FDA, were to undertake this inquiry in the first instance.

The resolution of the jurisdictional problem is advanced by consideration of two groups of Supreme Court opinions. In Abbott Laboratories v. Gardner, 387 U.S. 136, 87 S.Ct. 1507, 18 L.Ed.2d 681 (1967) and its companions,⁴ the Court held that self-operative administrative regulations of industry-wide application are not immune from pre-enforcement review by the district courts under the combined operation of the Declaratory Judgment Act, 28 U.S.C. § 2201, and the Administrative Procedure Act, 5 U.S.C. §§ 701-704. The proper application of the lower courts' power of review in the given case is, under Abbott Laboratories, essentially a question of ripeness.

"Without undertaking to survey the intricacies of the ripeness doctrine it is fair to say that its basic rationale is to prevent the courts, through avoidance of premature adjudication, from entangling themselves in abstract disagreements over administrative policies, and also to protect the agencies from judicial interference until an administrative decision has been formalized and its effects felt in a concrete way by the challenging parties. The problem is best seen in a twofold aspect, requiring us to evaluate both the fitness of the issues for judicial decision and the hardship to the parties of withholding court consideration." Id. at 149, 87 S.Ct. at 1515 (footnote omitted).

In assessing the first aspect in the case there under discussion, the Court placed great emphasis on the definitiveness of the regulation at issue. Not only did the character of the regulation make it a "final agency action" for purposes of Section 10 of the Administrative Procedure Act, 5 U.S.C. § 704, but it also ensured that the issue was fit for judicial decision.

"The regulation challenged here, promulgated in a formal manner after announcement in the Federal Register and consideration of comments by interested parties is quite clearly definitive. There is no hint that this regulation is informal, see Helco Products Co. v. McNutt, 78 U.S.App.D.C. 71, 137 F.2d 681, or only the ruling of a subordinate official, see Swift & Co. v. Wickham, D.C. 230 F.Supp. 398, 409, aff'd, 2 Cir. 364 F.2d 241, or tentative."

In contrast, in applying the Abbott Laboratories test to another regulation in a companion case, Toilet Goods Association, Inc. v. Gardner, 387 U.S. 158, 87 S.Ct. 1520, 18 L.Ed.2d 697 (1967), the Court found that the force and application of the second regulation were not so certain as to warrant the pre-enforcement review authorized in the former case. In Toilet Goods the plaintiffs, manufacturers and distributors of cosmetics, sought review of a regulation that authorized the FDA to suspend certification service to persons who refused FDA personnel access to manufacturing facilities, processes, and formulae used in the production of color additives. Because the regulation there in question was permissive only and the manner of its enforcement would be decided by the FDA Commissioner in light of a variety of regulatory considerations, the Court held that its validity would have to await determination at an actual enforcement proceeding.

Turning now to the instant case, the Court observes that the initial factual predicate of Abbott is lacking here, viz., the existence of an administrative regulation or other final agency action for which review could properly be sought here under the Administrative Procedure Act, supra. In other words, on the record before the Court and from its own diligent exploration of the Code of Federal Regulations and the Federal Register, it appears that there is no formal ruling or regulation declaring that Essiac is a new drug, not grandfathered by the latter portion of § 201(p)(1) of the Act.

The first suggestion by plaintiffs of the existence of such a regulation or ruling is to be found in paragraph 7 of the Complaint:

"That defendant's agents have caused an herbal tea, known as Essiac to be seized at the United States-Canadian border and have informed the individual plaintiffs that Essiac cannot be imported without a new drug identification number."

The only support of these allegations is the affidavit of Patricia Judson, attached to plaintiffs' brief in support of their Answer to defendant's Motion to Dismiss. Ms. Judson is identified only as a resident of Dearborn, Michigan and a non-party to this action. She asserts

"that during October of 1977, she

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