United States v. 431/2 Gross Rubber Prophylactics

• Decision Date: 11 February 1946
• Docket Number: Civil Action No. 1502.
• Citation: 65 F. Supp. 534
• Parties: UNITED STATES v. 43½ GROSS RUBBER PROPHYLACTICS LABELED IN PART "XCELLO'S PROPHYLACTICS" et al.
• Court: U.S. District Court — District of Minnesota

65 F. Supp. 534

UNITED STATES v. 43½ GROSS RUBBER PROPHYLACTICS LABELED IN PART "XCELLO'S PROPHYLACTICS" et al.

Civil Action No. 1502.

District Court, D. Minnesota, Fourth Division.

February 11, 1946.

Victor E. Anderson, U. S. Atty., and Clifford F. Hansen, Asst. U. S. Atty., both of St. Paul, Minn., for the United States.

Maurice Weinstein, of Milwaukee, Wis. (Ralph Stacker, of St. Paul, Minn., of counsel), for claimant.

NORDBYE, District Judge.

A libel of information was filed against the goods described in the caption on the theory that they were adulterated within the meaning of 21 U.S.C.A. § 351(c) and that they were misbranded within the meaning of 21 U.S.C.A. § 352(a). The goods were labeled "Prophylactics" on the carton in which they were contained, and the Government contends that such labeling constitutes misbranding within the meaning of the Act. The articles consist of certain rubber devices sold ostensibly for the purpose of preventing transmission of venereal disease. The government witnesses testified that, of the Xcello brand, 180 were tested and 14 contained holes; that 228 of the Silver-Tex brand were tested and 16 contained holes. Medical witnesses testified that the defective devices would not serve as a means for the successful prevention of the transmission of venereal disease.

Section 351 provides:

"A drug or device shall be deemed to be adulterated — * * *

"(c) If * * * its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess."

Section 352 provides:

"A drug or device shall be deemed to be misbranded —

"(a) If its labeling is false or misleading in any particular."

The government inspection has established that the devices tested were defective in the number indicated, and there can be no serious doubt that the strength and quality of these particular defective articles fell below that which they purported or were represented to possess. Furthermore, it seems clear that, being labeled "Prophylactics", there was misbranding within the meaning of the statute. These defectives devices are not efficacious in furnishing protection from disease.

The problem presented, however, pertains to the right of the Government to condemn the entire shipment. It appears that on or about June 19, 1945, about 43½ gross of the Xcello brand and 112½ gross of the Silver-Tex brand were shipped from the manufacturer in Akron, Ohio, to a concern in Minneapolis. It is from this shipment that the samples were taken and the tests made, as stated above. The Government took two samples — a pre-seizure and a post-seizure. While the method by which the first sample was taken is not entirely clear in the record, it does appear that, in taking the post-seizure samples, the Government took one dozen articles from each of the 36 gross cartons of Xcellos, and from the three gross so selected 72 samples were taken at random. Six, or about 8 per cent of the 72, were found to be defective. In the pre-seizure test of the Xcello brand, 108 were selected and 8 were found to be defective, or about 8 per cent. The post-seizure samples of the Silver-Tex brand were obtained by substantially the same method of selection by which the Xcello post-seizure samples were selected. In the post-seizure test of this brand, 120 samples were taken; four, or 3.33 per cent, were defective. In the pre-seizure test of this brand, 108 were tested and 12 were defective, or approximately 11.11 per cent. The average defects, therefore, of all the tests is approximately 7.37 per cent. But of the entire shipment seized, a fraction of one per cent is definitely shown to be defective, and claimant contends that the Government has failed to sustain the burden of proof which rests on it in these proceedings in its attempt to condemn the entire shipment. It should be pointed out that apparently the only practical tests which the government representatives are able to make with the facilities available to them results in the article's being rendered useless after the test has been made. Concededly, the burden of proof rests upon the Government. United States v. 5 One-Pint Bottles, et al., D.C. N.Y., 1934, 9 F.Supp. 990; United States v. 11¼ Dozen Packages, D.C.N.Y., 1941, 40 F.Supp. 208. But it does not follow that each individual article in the shipment must be tested. Inspection and condemnation on the basis of samples tested is clearly contemplated by the Act. In fact, the Act speaks of samples and their availability for testing. 21 U.S.C.A. § 334(c). And the cases seem to contemplate that testing of samples is sufficient if the samples are representative ones. Andersen & Co. v. United States, 9 Cir., 1922, 284 F. 542; United States v. 200 Cases et al., D.C.Tex. 1923, 289 F. 157. No serious question is raised in this proceeding as to the samples taken being representative. But claimant contends that the Court cannot order the condemnation of good articles, and concededly some of the remaining articles are in all probability free from defects. However, in urging this contention, claimant fails to distinguish between condemnation and the confiscation or sale of goods. Condemnation only sustains the Government's position that the goods as they were composed in interstate shipment violate the provision and purpose of the Federal Food, Drug, and Cosmetic Act. After the decree, the claimant can separate the good from the defective if it posts a bond, and thereby will be able to retain the balance of the goods. 21 U.S.C.A. § 334(d). The very fact that part of the section of the Food and Drug Act which governs condemnation and confiscation procedure contains a section which permits the separation of the acceptable from the defective goods after condemnation indicates an intent and recognition by Congress that some of the shipment may not violate the Act, but nevertheless would be subject to a decree of condemnation together with the defective merchandise. In view of the fact that the tests which the government representatives have applied render the articles useless, it is highly improbable that the statute intended that only the defective articles are to be...