Table of Contents
FDA Consumer magazine
March-April 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: Frozen Shrimp, at Tampa, Fla. (M.D. Fla.); Civil Action No. 97-2826-CIV-T-26(C).
CHARGED 11-26-97: While held for sale after shipment in interstate commerce at Americold Corporation, in Tampa, Fla., the articles were adulterated in that they consisted in whole or in part of decomposed shrimp--402(a)(3).
DISPOSITION: Pursuant to a consent decree of condemnation and destruction, the articles were destroyed. (F.D.C. No. 67215;
S. No. 97-712-439; S. No. 1)

Drugs/Human Use

PRODUCT: Oxygen, at Dolton, Ill. (N.D. Ill.); Civil Action No. 95-C-3525.
CHARGED 6-15-95: While held for sale after shipment in interstate commerce at Daley's Medical Rental, Inc., Dolton, Ill., the article of drug was adulterated in that the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice requirements (GMP's) of the Food, Drug, and Cosmetic Act--501(a)(2)(B).
DISPOSITION: The article of drug was reconditioned. (F.D.C. No. 67094; S. No. 95-662-365; S.J. No. 2)

PRODUCT: Prescription and Over-the-Counter Ointments, at Sioux City, Iowa (N.D. Iowa); Civil Action No. 97cv4052.
CHARGED 6-11-97: While held for sale after shipment in interstate commerce at Medco Lab, Inc., in Sioux City, Iowa, the articles 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) to ensure that such drugs met the safety requirements of the Food, Drug, and Cosmetic Act--501(a)(2)(B). The articles of drug were misbranded in that they lacked adequate directions for use since adequate directions for use could not be written for unapproved new drugs--502(f)(1); and the labels on the articles of drug failed to bear warnings required by 21 C.F.R. 330.1(g)--502(f)(2).
DISPOSITION: The articles of drug were destroyed.(F.D.C. No. 67157; S. No. 97-688-630; S.J. No. 3)

PRODUCT: Various articles of drug, at Fort Lauderdale, Fla. (S.D. Fla.); Civil Action No. 98-6006.
CHARGED 1-5-98: While held for sale after shipment in interstate commerce at Anda Generics, Inc., in Fort Lauderdale, Fla., 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 to ensure that such drugs met the safety requirements of the Federal Food, Drug, and Cosmetic Act--501(a)(2)(B). The drugs were misbranded in that their labeling failed to bear adequate directions for use and they were not exempt from such requirement under 21 CFR 201.115 since the articles were unapproved new drugs--502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67218; S. No. 97-768-490; S.J. No. 4)

Medical Devices

PRODUCT: Surgical steel instruments, at Baltimore, Md. (D. Md.); Civil Action No. AMD-98-846.
CHARGED 3-23-98: While held for sale after shipment in interstate commerce at Overflow Public Storage Warehouse, Inc., in Baltimore, Md., the articles of device were adulterated in that the methods used in, or the facilities or controls used for, their manufacture, packaging, storage, or installation were not in conformity with the current good manufacturing practice (CGMP) requirements of the Quality System Regulation--501(h). The articles were also adulterated in that their quality fell below that which they purported or were represented to possess--501(c). The articles were misbranded in that the foreign manufacturer (Mars Enterprises) was not included in a list required by 21 U.S.C. Section 510(j) and the domestic manufacturer (Zee International) was not registered as a manufacturer of medical devices as required by 21 U.S.C. Section 510, and was not included in a list required by 21 U.S.C. Section 510(j)--502(o).
DISPOSITION: The articles were destroyed by incinerator. (F.D.C. No. 67221; S. No. DI 98-716-798; S.J. No. 5)

INJUNCTION ACTIONS

DEFENDANT: Joseph M. Thomas, at Carlisle, Pa. (M.D. Pa.); Civil Action No. 1:CV-97-0140.
CHARGED 1-29-97: The cattle and calves and the edible tissues of those animals were adulterated in that they contained new animal drugs which were unsafe within the meaning of 21 U.S.C. Section 512--402(a)(2)(D). The cattle and calves, and their edible tissues, were also adulterated because such cattle and calves had been held under insanitary conditions whereby their edible tissues might have been rendered injurious to health, in that the defendant did not implement or maintain an adequate record-keeping system concerning the medicated status of the animals, nor did the defendant ensure that the required withdrawal periods were observed--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was filed. (Inj. No. 1398; S. No. 96-786-706; S.J. No. 6)

DEFENDANTS: Finest Foods, Inc., d.b.a. Mrs. Drake's Sandwiches, and James W. Ganus, James W. Ganus Jr., Robert W. Ganus, and Ronald Blanchard, at New Orleans, La. (E.D. La.); Civil Action No. 93-0746.
CHARGED 3-5-93: The defendants prepared and held for sale after shipment in interstate commerce articles of food that they caused to become adulterated--301(k). The articles of food were adulterated in that they were prepared, packed or held under insanitary conditions whereby they might have become contaminated with filth--402(a)(4). The articles were further adulterated in that they contained Listeria monocytogenes, a poisonous and deleterious substance which may have rendered the food injurious to health--402(a)(1).
DISPOSITION: A consent decree of permanent injunction and an amended consent decree of permanent injunction were filed. Subsequently, all articles of food contaminated with L. monocytogenes bacteria or filth were destroyed. (Inj. No. 1317; S. No. 93-689-981; S.J. No. 7)

DEFENDANT: Marilyn Jarzembski, d.b.a. Quality Health Products, at Fayette, Ohio (N.D. Ohio); Civil Action No. 3:97CV7573.
CHARGED 8-14-97: The defendant introduced adulterated and misbranded medical devices into interstate commerce and refused to permit entry or inspection as authorized by 21 U.S.C. Section 704--301(a) and 301(f). The articles of device, "Ear Candles", were adulterated in that they were class III devices that had no premarket approval in effect as required by 21 U.S.C. Section 515, and were not approved for use in accordance with an Investigational Device Exemption ("IDE") pursuant to 21 U.S.C. Section 520(g)--501(f)(1)(B). In addition, the devices were adulterated in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation were not in conformity with current good manufacturing practice requirements--501(h).
The devices were misbranded in that their labeling failed to bear adequate directions for use because the directions provided by the defendant were not directions under which the consumer could have used the Ear Candles safely and for their intended purpose--502(f)(1). The devices were misbranded in that they were dangerous to health when used as directed because hot wax and smoke could have entered the ear canal and caused burns and temporary hearing loss--502(j). The devices were further misbranded in that they were manufactured, prepared and processed in an establishment not duly registered under 21 U.S.C. Section 510, because they were not included in a list, as required by 21 U.S.C. Section 510(j), and because no premarket notifications respecting the devices had been filed as required by 21 U.S.C. Section 510(k)--502(o).
DISPOSITION: A consent decree of permanent injunction was filed. The articles of device were destroyed. (Inj. 1407; S. No. 96-765-297; S.J. No. 8)

DEFENDANT: Richard Dykast, at Opa Locka, Fla. (S.D. Fla.); Civil Action No. 97-1083.
CHARGED 4-18-97: The defendant introduced into interstate commerce, articles of drugs that were new drugs within the meaning of 21 U.S.C. Section 201(p), which were neither approved under 21 U.S.C. Section 505(a) nor exempt from such approval provisions under 21 U.S.C. Section 505(i) and CFR Section 312.2--301(d). The articles 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 or administered in conformity with, current good manufacturing practice--501(a)(2)(B). The articles were misbranded in that they were manufactured, compounded or processed in an establishment that was not duly registered under 21 U.S.C. Section 510(b) and were not listed as required by 21 U.S.C. Section 510(j)--502(o).
DISPOSITION: A consent decree of permanent injunction was filed. The articles were destroyed. (Inj. No. 1403; S. No. 96-712-054; S.J. No. 9)

DEFENDANTS: Siemens Medical Systems, Inc., and Robert V. Dumke, at Iselin, N.J. (D. N.J.); Civil Action No. 94-912(JWB).
CHARGED 2-24-94: The defendants manufactured, imported and distributed articles of device which were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, packing, storage, and installation were not in conformity with current good manufacturing practice regulations for medical devices--501(h).
DISPOSITION: A consent decree of permanent injunction was filed. The defendant, however, satisfied all of the requirements of the decree and it was thereby dissolved pursuant to court order. (Inj. No. 1331; S. No. 93-628-468/471; S.J. No. 10)

MISCELLANEOUS ACTIONS

ACTION: Citizens Commission on Human Rights v. FDA, at Los Angeles, Calif. (C.D. Calif.); Civil Action No. CV-92-5313.
CHARGED 9-1-92: The plaintiff, an organization founded by the Church of Scientology, submitted a Freedom of Information Act (FOIA) request in June 1992 seeking all information concerning the antidepressant drug Prozac, which is manufactured by Eli Lilly and Company. The plaintiff alleged that FDA had improperly responded to the FOIA request and unlawfully withheld records.
DISPOSITION: On May 10, 1993, the district court granted the government's motion for summary judgment and in doing so found that FDA had conducted an adequate search in response to plaintiff's FOIA request by examining approximately 350,000 pages from the Prozac new drug application ("NDA"), disclosing approximately 10,000 pages to the plaintiff, and compiling, with Lilly, a 563-page index of documents in the NDA that are exempt from disclosure. The court also found that FDA properly withheld trade secret, confidential commercial, and deliberative information in the NDA. The plaintiff appealed, and the appellate court, affirmed in part the lower court's decision. The court of appeals held that FDA's search for responsive records was adequate; the index of documents was not defective; and the district court's denial of plaintiff's request for discovery was not an abuse of discretion. The appellate court, however, remanded to the district court an issue involving individual adverse reaction reports that FDA did not disclose to plaintiff, because (according to FDA) plaintiff did not specifically request them. The reports are publicly available after redaction of personal privacy information. (MISC 982; S. No. No. 92-5313; S.J. No. 11)

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