Table of Contents
FDA Consumer magazine
July-August 1999

Summaries of Court Actions

Summaries of Court Actions are given pursuant to Section 705 of the Federal Food, Drug, and Cosmetic Act. Summaries of Court Actions report cases involving seizure proceedings, criminal proceedings, and injunction proceedings. Seizure proceedings are civil actions taken against goods alleged to be in violation, and criminal and injunction proceedings are against firms or individuals charged to be responsible for violations. The cases generally involve foods, drugs, devices, or cosmetics alleged to be adulterated or misbranded or otherwise violative of the law when introduced into and while in interstate commerce.
Summaries of Court Actions are prepared by the Office of the Chief Counsel, Food and Drug Administration.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Shrimp, frozen, peeled, at Tampa, Fla. (M.D. Fla.); Civil Action No.
95-1575-Civ-T-24(B).
CHARGED 9-25-95: While held for sale after shipment in interstate commerce at Americold, in Tampa, Fla., the articles of food were adulterated in that they consisted in whole or in part of decomposed shrimp--402(a)(3).
DISPOSITION: Claimants appealed the district court's order that required them to pay costs incurred by the State of Florida, but the U.S. Court of Appeals of the Eleventh Circuit affirmed the district court's order. The articles were reconditioned into "chum", or fish bait. (F.D.C. No. 67101; S. No. 95-681-946; S.J. No. 1)

PRODUCT: Shrimp, frozen, at St. Petersburg, Fla. (M.D. Fla.); Civil Action No.
95-1947-Civ-T-24(C).
CHARGED 11-24-95: While held for sale after shipment in interstate commerce at Sigma International, Inc., in St. Petersburg, Fla., the articles of food were adulterated in that they consisted in part of decomposed shrimp--402(a)(3).
DISPOSITION: Claimants appealed the district court's order that required them to pay costs incurred by the State of Florida but the U.S. Court of Appeals of the Eleventh Circuit affirmed the district court's order. The articles were reconditioned into "chum", or fish bait. (F.D.C. 67114; S. No. 95-712-273; S.J. No. 2)

PRODUCT: Shrimp, frozen, at Tampa, Fla. (M.D. Fla.); Civil Action No. 96-2602-Civ-T-24(E).
CHARGED 12-18-96: While held for sale after shipment in interstate commerce at Americold Corporation, in Tampa, Fla., the articles of food were adulterated in that they were washed in Sea Fresh, a commercially available aqueous solution containing copper sulfates, and in chlorine, lemon juice, and phosphates to conceal damage or inferiority of the defendant shrimp, and were made to appear of greater value than they were--402(b)(3) and 402(b)(4). The articles were further adulterated in that they consisted in part of decomposed shrimp--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67163; S.J. No. 3)

PRODUCT: Shrimp, frozen, at St. Petersburg, Fla. (M.D. Fla.); Civil Action No.
96-2603-Civ-T-24(C).
CHARGED 12-18-96: While held for sale after shipment in interstate commerce at Sigma International, Inc., in St. Petersburg, Fla., the articles of food were adulterated in that they were washed in Sea Fresh, a commercially available aqueous solution containing copper sulfate, and in chlorine, lemon juice, and phosphates to conceal damage or inferiority of the defendant shrimp, and were made to appear of greater value than they were--402(b)(3) and 402(b(4). The articles were further adulterated in that they consisted in part of decomposed shrimp--402(a)(3).
DISPOSITION: Claimants appealed the district court's order that required them to pay costs incurred by the State of Florida but the U.S. Court of Appeals of the Eleventh Circuit affirmed the district court's order. The articles were reconditioned into "chum", or fish bait. (F.D.C. No. 67164; S.J. No. 4)

PRODUCT: Shrimp, frozen, at Plant City, Fla. (M.D. Fla.); Civil Action No.
96-2601-Civ-T-25(B).
CHARGED 12-19-96: While held for sale after shipment in interstate commerce at Tampa/Lakeland Refrigerated Services, in Plant City, Fla., the articles of food were adulterated in that they were washed in Sea Fresh, a commercially available aqueous solution containing copper sulfate, and in chlorine, lemon juice, and phosphates to conceal damage or inferiority of the defendant shrimp, and were made to appear of greater value than they were--402(b)(3) and 402(b)(4). The articles of food were further adulterated in that they consisted in part of decomposed shrimp--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67165; S.J. No. 5)

PRODUCT: Shrimp, frozen, at St. Petersburg, Fla. (M.D. Fla.); Civil Action No.
97-197-Civ-T-24(A).
CHARGED 2-5-97: While held for sale after shipment in interstate commerce at Sigma International, Inc., in St. Petersburg, Fla., the articles of food were adulterated in that they consisted in whole or in part of decomposed shrimp--402(a)(3).
DISPOSITION: Claimants appealed the district court's order that required them to pay costs incurred by the State of Florida, but the U.S. Court of Appeals of the Eleventh Circuit affirmed the district court's order. Furthermore, the articles were reconditioned into "chum", or fish bait. (F.D.C. No. 67167; S.J. No. 6)

PRODUCT: Shrimp, frozen, at Plant City, Fla. (M.D. Fla.); Civil Action No.
97-198-Civ-T-23(A).
CHARGED 2-5-97: While held for sale after shipment in interstate commerce at Tampa/Lakeland Refrigerated Services, in Plant City, Fla., the articles of food were adulterated in that they consisted in part of decomposed shrimp--402(a)(3).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67168; S.J. No. 7)

PRODUCT: Wheat, Light-Brown, Oblong-Shaped, at Naples, Ill. (C.D. Ill.); Civil Action No. 94-3007.
CHARGED 1-13-94: While held for sale after shipment in interstate commerce at Consolidated Grain and Barge Co., in Naples, Ill., the article of food was adulterated in that it consisted in whole or in part of a filthy substance by reason of the presence therein of insects--402(a)(3).
DISPOSITION: Pursuant to a consent decree of condemnation, the article was reconditioned. (F.D.C. No. 66913; S. No. 94-611-032; S.J. No. 8)

Drugs/Human Use

PRODUCT: Acne cream, at Bronx, N.Y. (E.D. N.Y.); Civil Action No. 98-CIV-3962.
CHARGED 6-4-98: While held for sale after shipment in interstate commerce at Nels Laboratories, Inc., in Bronx, N.Y., the articles of drug for the treatment of acne were misbranded in that their labeling failed to bear adequate directions for use and failed to bear adequate warnings--502(f)(1) and 502(f)(2).
DISPOSITION: Pursuant to a default judgment, the articles were destroyed. (F.D.C. 67231; S. No. 98-751-265; S.J. No. 9)

PRODUCT: Oxygen, at New Iberia, La. (W.D. La.); Civil Action No. 98-1363.
CHARGED 7-24-98: While held for sale after shipment in interstate commerce at Welder's Equipment Center of New Iberia, Inc., in New Iberia, La., the articles of drug were adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current Good Manufacturing Practice (GMP) regulations--501(a)(2)(B). The articles were misbranded in that the labels of the high-pressure cylinders failed to bear an accurate statement of the quantity of contents--502(b)(2).
DISPOSITION: Pursuant to a consent decree of condemnation, the articles were reconditioned. (F.D.C. No. 67234; S. No. 98-763-239; S.J. No. 10)

PRODUCT: Oxygen, at Hendersonville, Tenn. (M.D. Tenn.); Civil Action No. 3-98-0170.
CHARGED 2-25-98: While held for sale after shipment of one or more of their components in interstate commerce at Ed Medical, Inc., in Hendersonville, Tenn., the articles of drug were adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice (GMP) regulations--501(a)(2)(B). The articles were misbranded in that the labels of the cryogenic home units failed to bear adequate directions for use--502(f)(1).
DISPOSITION: Pursuant to a consent decree of condemnation, the articles were reconditioned. (F.D.C. No. 67208; S. No. 97-777-010; S.J. No. 11)

PRODUCT: Oxygen, at Mankato, Minn. (D. Minn.); Civil Action No. 97-2310.
CHARGED 10-16-97: While held for sale after shipment of one or more of their components in interstate commerce at Praxair Distribution, Inc., in Mankato, Minn., the articles of drug were adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice--501(a)(2)(B). The articles were misbranded in that the labels of the cryogenic home units failed to bear adequate directions for use--502(f)(1). The articles were further misbranded in that the labeling of the cryogenic vessels failed to bear the statement "Caution: Federal law prohibits dispensing without prescription"--503(b)(4).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67207; S. No. 97-557-804; S.J. No. 12)

Drugs/Veterinary Use

PRODUCT: Veterinary Drugs, at Des Moines, Iowa (S.D. Iowa); Civil Action No. 4-98-CV-90941.
CHARGED 9-11-98: While held for sale after shipment in interstate commerce at Mortar & Pestle Veterinary Pharmacy, Inc., in Des Moines, Iowa, the articles of drug were adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practices ("GMP")--501(a)(2)(B). The articles were further adulterated in that they were unapproved new animal drugs within the meaning of 21 U.S.C. Section 321(v)(1)--501(a)(5). The articles were misbranded in that they failed to bear adequate directions for use--502(f)(1).
DISPOSITION: The FDA district office is working with the claimant and the U.S. Marshal's Service to get the claimed articles reconditioned and the unclaimed articles destroyed. (F.D.C. No. 67240; S. No. 98-688-688 et al.; S.J. No. 13)

Medical Devices

PRODUCT: Baoding Iron Balls, 65 cases, more or less, and accompanying booklet, at Hanover, Pa. (M.D. Pa.); Civil Action No. 1:CV-93-1842.
CHARGED 11-29-93: While held for sale after shipment in interstate commerce at Hanover Direct, Inc., in Hanover, Pa., the article of device was adulterated in that it was a Class III device under 21 U.S.C. Section 360c(f), and there was no approved premarket approval application in effect pursuant to 21 U.S.C. Section 360e--501(f)(1)(B). The article was misbranded in that its labeling was false and misleading and otherwise contrary to fact and failed to bear adequate directions for use for the purpose for which the article was intended--502(a) and 502(f)(1). The article was further misbranded in that it was manufactured, prepared and processed in an establishment not duly registered under 21 U.S.C. Section 360, it was not included in the list required by 21 U.S.C. Section 360(j), and a notice or other information respecting the device was not provided as required by 21 U.S.C. Section 360(k)--502(o).
DISPOSITION: A default decree was entered on March 29, 1994, but on the day that destruction was scheduled to take place, the U.S. marshals discovered that the product had been removed by Hanover Direct, Inc., the distributor. The government considered criminal and injunctive relief against Hanover and ultimately negotiated a consent decree of condemnation and injunction. A consent motion to vacate the default judgment together with a claim and the consent decree were filed on Feb. 27, 1996. (F.D.C. No. 66797; S. No. 93-634-611; S.J. No. 14)

PRODUCT: Latex Examination Gloves, at Sacramento, Calif. (E.D. Calif.); Civil Action No. S-98-1422 LKK JFM.
CHARGED 7-24-98: Defendant property was seized pursuant to a federal search warrant executed at Alliance Medical Supplies, Inc., in North Highlands, Calif. and put into the possession of the U.S. Postal Service in Sacramento, Calif. The defendant article was adulterated in that it was a device which was classified under 21 U.S.C. Section 360c(f)(1) into Class III and there was no approved application for premarket approval in effect pursuant to 21 U.S.C. Section 360(e) and no investigational device exemption in effect pursuant to 21 U.S.C. Section 360j(g)--501(f)(1)(B). The article was misbranded in that a notice or other information respecting the device was not provided to the Food and Drug Administration at least 90 days prior to introduction into interstate commerce as required by 21 U.S.C. Section 360(k)--502(o).
DISPOSITION: The seized products were destroyed. (F.D.C. No. 67243; S. No. 94-704-901/906; S.J. No. 15)

PRODUCT: Ultrasound Scanner System, at Gainesville, Ga. (N.D. Ga.); Civil Action No. 2:96-CV-0085-WCO.
CHARGED 6-17-96: While held for sale after shipment in interstate commerce, the article of device was misbranded in that its labeling failed to bear adequate directions for use for the purposes for which it was intended, and the article was not exempt from the requirements of 21 U.S.C. Section 352(f)(1) under 21 C.F.R. Section 801.109, because it was not being used on the prescription or other order of a licensed practitioner in the course of his or her professional practice--502(f)(1). Furthermore, the article was adulterated in that when used for unapproved indications, it was a Class III device under 21 U.S.C. Section 360c(f) and it did not have an approved application for premarket approval in effect pursuant to 21 U.S.C. Section 360e or an approved application for an investigational device exemption under 21 U.S.C. Section 360j(g)--501(f)(1)(B).
DISPOSITION: The seized device was released to the claimant upon payment of costs. The claimant entered into a consent decree enjoining her from using the device without a written prescription from a licensed practitioner, and from distributing promotional literature without the statement that a written prescription was required. (F.D.C. No. 67134; S. No. 96-720-397; S.J. No. 16)

INJUNCTION ACTIONS

DEFENDANT: Veterinary Pharmaceuticals, Inc., and Sierra Pharmaceutical, Inc., and Harold M. Des Jardins and James K. Mann, at Hanford, Calif. (E.D. Calif.); Civil Action No. CIV F-99-5222.
CHARGED 3-3-99: At their Sierra plant in Mexicali, B.C., Mexico, the defendants produced various veterinary pharmaceuticals to be imported into and distributed within the United States. These pharmaceuticals were parenteral, or injectable, products intended for use in the cure, mitigation, treatment, or prevention of disease in animals, and were therefore drugs within the meaning of the Food, Drug, and Cosmetic Act, 21 U.S.C. 321 (g)(1)(B).
The products were misbranded in that they were dangerous to health when used in the dosage or manner or with the frequency or duration prescribed, recommended or suggested in the labeling thereof--502(j). The products were further misbranded in that their labeling was false and misleading--502(a). The products were adulterated because their purity or quality fell below that which they purported or were represented to possess--501(c). The products were further adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packing, or holding did not conform to or were operated or administered in conformity with current good manufacturing practice--502(a)(2)(B).
DISPOSITION: A consent decree of permanent injunction was filed, and the parenteral products were destroyed. (Inj. No. 1431; S. No. 98-733-228; S.J. No. 17)

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