United States v. 14 CASES, ETC.,(BAG)" NAREMCO MEDI-MATIC

• Decision Date: 29 January 1974
• Docket Number: Civ. A. No. 2806.
• Citation: 374 F. Supp. 922
• Parties: UNITED STATES of America, Plaintiff, v. 14 CASES, MORE OR LESS, each containing 6 bags Labeled in part: (BAG) "NAREMCO MEDI-MATIC FREE CHOICE POULTRY FORMULA (medicated) * * * Net Weight 10 lbs. * * * Active drug ingredients: methylrosaniline chloride...0.0198% sodium phthalysulfacetamide...0.176% sodium propionate ...1.5% iron (FE)...0.072% Copper (CU)...0.036% Cobalt (CO) ...0.00012% ingredients: * * * Guaranteed analysis: * * * directions for use * * * Naremco 1724 Mt. Vernon, Springfield, Missouri 65805", et al., Naremco, Inc., Defendant.
• Court: U.S. District Court — Western District of Missouri

374 F. Supp. 922

UNITED STATES of America, Plaintiff, v. 14 CASES, MORE OR LESS, each containing 6 bags Labeled in part: (BAG) "NAREMCO MEDI-MATIC FREE CHOICE POULTRY FORMULA (medicated) * * * Net Weight 10 lbs. * * * Active drug ingredients: methylrosaniline chloride...0.0198% sodium phthalysulfacetamide...0.176% sodium propionate ...1.5% iron (FE)...0.072% Copper (CU)...0.036% Cobalt (CO) ...0.00012% ingredients: * * * Guaranteed analysis: * * * directions for use * * * Naremco 1724 Mt. Vernon, Springfield, Missouri 65805", et al., Naremco, Inc., Defendant.

Civ. A. No. 2806.

United States District Court, W. D. Missouri, S. D.

January 29, 1974.

COPYRIGHT MATERIAL OMITTED

Bert C. Hurn, U. S. Atty., Mary Ann Senner, Asst. U. S. Atty., Kansas City, Mo., Jay H. Geller, U. S. Dept. of Health, Education and Welfare, Washington, D. C., for plaintiff.

O. J. Taylor, Springfield, Mo., for defendant.

MEMORANDUM OPINION AND JUDGMENT

COLLINSON, District Judge.

This is a seizure and condemnation action brought under the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. §§ 301-392 (1970), to condemn a quantity of drugs known as "Myconox Medicated" (Myconox) and "Medi-Matic Free Choice Poultry Formula" (Medi-Matic). Plaintiff alleges that each article is a drug which is adulterated and misbranded while being held for sale after shipment in interstate commerce; and that, therefore, each drug is subject to seizure and condemnation within the ambit of section 334(a)(1) of the Act.¹ Specifically, plaintiff alleges that each drug is adulterated within the meaning of section 351(a)(5),² in that each is a "new animal drug" section 321(w)³ which is unsafe section 360b(a)(1) (A)⁴ since no approval of an application filed pursuant to section 360b(b)⁵ is in effect with respect to either drug. Further, plaintiff contends that each drug is misbranded within the meaning of section 352(a).⁶

Pursuant to the complaint, the drugs were seized on November 1, 1971, by the United States Marshal for this district. Thereafter, Naremco, Inc. (claimant), intervened and filed a claim and answer.

Plaintiff filed a motion for summary judgment on the grounds (1) that Myconox should be condemned on a res judicata basis; (2) that there is no genuine issue of a material fact that both of the seized drugs are adulterated; and (3) that there is no genuine issue of material fact that Myconox is misbranded. Summary judgment is not sought on the misbranding allegation against Medi-Matic. Claimant has filed suggestions in opposition to plaintiff's motion for summary judgment and filed its own motion for summary judgment on the basis that this Court is without jurisdiction since only a fractional percentage of the composition of these drugs was alleged to have been shipped in interstate commerce. In addition, claimant has filed a motion for partial summary judgment on the issue of misbranding of the drug Medi-Matic on the basis of res judicata. Claimant has also filed a motion to dismiss or, in the alternative, for an indefinite stay of proceedings on the basis that claimant was denied due process of law because of different and allegedly discriminatory procedures and policies of enforcement between over-the-counter drugs for human usage and over-the-counter drugs for animal usage. The plaintiff has filed suggestions in opposition to each of these motions.

In light of the recent Supreme Court decisions⁷ concerning definitions of certain statutory language which is dispositive of this case, it will be unnecessary for the Court to consider the res judicata arguments raised by the parties. Claimant's other motions raise questions of law which we must decide before ruling on the plaintiff's motion for summary judgment.

Claimant's Motion for Summary Judgment: In its motion for summary judgment, claimant challenges the jurisdiction of this Court, and presumably the legality of plaintiff's seizure of these drugs. Claimant argues that the only allegations connecting these drugs with interstate commerce is that methylrosaniline chloride (gentian violet), an active ingredient in both drugs, was shipped from Cincinnati, Ohio, to Springfield, Missouri. Claimant does not dispute that the gentian violet was shipped in interstate commerce, but does contend that since this ingredient constitutes only .66 of 1 per cent of the composition of Myconox, and only .0198 of 1 per cent of Medi-Matic, these drugs would not be subject to the Act. In support of this position, claimant cites several cases which have held that an article is not subject to the Act where the only components shipped in interstate commerce were either minor ingredients of the final product, or components which lost their identity in the combined product. E. g., United States v. 39 Cases, . . ., 192 F.Supp. 51 (E.D. Mich.1961); United States v. 40 Cases, . . ., 188 F.Supp. 290 (N.D.N.Y. 1960), rev'd, 289 F.2d 343 (2d Cir. 1961); United States v. An Article or Device Consisting of 31 Units . . ., 180 F.Supp. 52 (E.D.Mich.1959). The ingredient shipped in the instant case was an active ingredient, however, and this is sufficient to bring these drugs within the purview of the Act. "Shipment of the active ingredient of a drug is the equivalent of shipping the drug." Palmer v. United States, 340 F.2d 48, 49 (5th Cir. 1964), cert. denied, 382 U.S. 903, 86 S.Ct. 238, 15 L.Ed.2d 156 (1965). See also United States v. 40 Cases, . . ., 289 F.2d 343, 345 (2d Cir. 1961), cert. denied, 368 U.S. 831, 82 S.Ct. 54, 7 L.Ed.2d 34 (1962).

Claimant's Motion to Dismiss: In its motion to dismiss or for an indefinite stay of proceedings, claimant alleges that the Commissioner of the Food and Drug Administration (FDA) has established a policy of non-enforcement against over-the-counter drugs for human use pending review of those drugs while adopting a policy of enforcement against veterinary over-the-counter drugs without such review.⁸ This difference between the procedures for similar drugs subject to similar provisions of the Act, claimant contends, is discriminatory and so arbitrary, capricious, unreasonable and irrational as to be violative of due process.

We believe that claimant's argument is without merit. The due process clause of the Fifth Amendment bars only invidious discrimination or classifications which are utterly lacking in rational justification. Flemming v. Nestor, 363 U.S. 603, 611-612, 80 S.Ct. 1367, 4 L.Ed.2d 1435 (1960); Williamson v. Lee Optical Co., 348 U.S. 483, 489, 75 S. Ct. 461, 99 L.Ed. 563 (1955). A classification which is reasonable in relation to its subject matter and adopted in the community interest satisfies due process. West Coast Hotel Co. v. Parrish, 300 U.S. 379, 391, 57 S.Ct. 578, 81 L.Ed. 703 (1937). Claimant has failed to show either invidious discrimination or an arbitrary or capricious classification resulting from the FDA's procedures or policies. Further, it is well established that administrative agencies have broad discretion in advancing the objectives of Congress, Pan American Airways, Inc. v. CAB, 129 U.S.App.D.C. 159, 392 F. 2d 483, 496 (1968), and the relationship of a remedy to policy decisions by the agency is peculiarly a matter of administrative competence. NLRB v. Seven-Up Bottling Co., 344 U.S. 344, 349, 73 S.Ct. 287, 97 L.Ed. 377 (1953); Phelps Dodge Corp. v. NLRB, 313 U.S. 177, 194, 61 S.Ct. 845, 85 L.Ed. 1271 (1941); NLRB v. Luisi Truck Lines, 384 F.2d 842, 847 (9th Cir. 1967). The Courts must give deference to the choice of remedy made by an administrative agency unless it reflects abuse of discretion. United Steelworkers v. NLRB, 126 U.S. App.D.C. 215, 376 F.2d 770, 773 (D.C. Cir.), cert. denied, 389 U.S. 932 (1967). We find no suggestion of such abuse here; the rationale of the procedure for over-the-counter drugs for human use has been explained in detail by the FDA,⁹ as has the relationship of this procedure to other classes of drugs.¹⁰ There being a rational basis for the difference in procedures and no showing of abuse of discretion, we need pursue this issue no further.

Plaintiff's Motion for Summary Judgment: Rule 56(c), Fed.R.Civ.P., provides that summary judgment must be granted where the pleadings and discovery materials, together with affidavits, if any, show conclusively that there is no genuine issue as to a material fact and that the moving party is entitled to judgment as a matter of law. Summary judgment is appropriate in seizure actions under the Act. See Tyler Pharmacal Distributors, Inc. v. U.S. Department of Health, Education and Welfare, 408 F.2d 95, 99 (7th Cir. 1969); AMP, Inc. v. Gardner, 389 F.2d 825 (2d Cir.), cert. denied 393 U.S. 825, 89 S.Ct. 86, 21 L.Ed.2d 95 (1968); United States v. 354 Bulk Cartons . . . Trim Reducing-Aid Cigarettes, 178 F.Supp. 847 (D. N.J.1959).

The dispositive question in this motion for summary judgment is whether the seized articles of drug, Medi-Matic and Myconox, are adulterated within the meaning of 21 U.S.C. § 351(a)(5) (1970). Under the 1968 amendments to the Act, section 351 was amended to include "new animal drugs" which are not the subject of a new animal drug application (NADA) filed pursuant to 21 U.S.C. § 360b(b) (1970). Claimant has admitted that there have been no new animal drug applications filed for the seized drugs.¹¹ Thus the issue presented is whether these drugs are "new animal drugs" as defined in 21 U.S.C. § 321(w)(1) (1970). That definition reads in pertinent part:

. . . any drug intended for use for animals other than man, including any drug intended for use in animal feed . . . (1) 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 animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling thereof. . . . (emphasis added)

The statutory definition is controlling despite any common...