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FDA Consumer magazine
July-August 2000
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.
PRODUCT: Straw Mushrooms, 2,216 cases, more or less, at Jersey
City, N.J. (D. N.J.); Civil Action No. 99-4012.
CHARGED 8-25-99: While held for sale after shipment in interstate commerce at Well Luck Co., Inc., in Jersey City, N.J., the article of food was misbranded in that its labeling was false and misleading because the invoice falsely represented that it had been packed by Kepper Food Processor Co.--403(a)(1). The article of food was adulterated in that it had been prepared and packed under conditions whereby it may have been rendered injurious to health because of inadequate processing--402(a)(4).
DISPOSITION: The article was destroyed. (F.D.C. No. 67274; S. No.122-0141337-9; S.J. No. 1)
PRODUCT: Surgical steel instruments, 10 cases, more or less,
at Alexandria, Va. (E.D. Va.); Civil Action No. 97-CV-2088.
CHARGED 12-30-97: While held for sale after shipment in interstate commerce at Matrix International Logistics, Inc., in Alexandria, Va., the articles of device were adulterated in that their quality fell below that which they were purported or were represented to possess because they contained rust, pits, and corrosion, and they lacked the ease of movement required by surgical steel instruments, which caused the instruments to fall below the quality expected of surgical steel instruments --501(c). The articles of devices were misbranded in that their labeling was false and misleading since it stated that the devices were made in the United States and some of the devices had the word "Pakistan" etched into them--502(a).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67213; S. No. 97-645-979; S.J. No. 2)
PRODUCT: Oxygen, U.S.P., at Nashville, Tenn. (M.D. Tenn.);
Civil Action No. 3:98-1148.
CHARGED 12-11-98: While held for sale after shipment of one or more of their components in interstate commerce, the articles of drug were adulterated in that the methods 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 assure that such drugs met the safety requirements of the Food, Drug, and Cosmetic Act and had the identity and strength, and met the quality and purity characteristics which they purported, and were represented to possess--501(a)(2)(B). The high pressure cylinders were misbranded in that their label failed to bear an accurate statement of the quality of the contents; and the cryogenic home units' labeling failed to bear, at a minimum, the symbol "Rx only."--502(b)(2) and 503(b)(4)(A).
DISPOSITION: The United States Marshals Service executed the Warrant for Arrest In Rem issued by the Court and seized the articles on December 22, 1998. During settlement negotiations, Medical Homecare Services, Inc.'s counsel informed the United States that Gayle Sensing had removed the "Restricted Area" tape and the USMS' "No Trespassing" seal, taken the cylinders and vessels, vented the oxygen into the atmosphere, and sent the empty containers to another oxygen transfiller. Following an inspection at Medical Homecare Services by FDA investigators, the government filed a Motion for Show Cause Order, which the Court granted, and a hearing was held on the contempt issue on September 30, 1999. (F.D.C. No. 67252; S. No. 98-679-508; S.J. No. 3)
PRODUCT: Various Topical Products (Corticosteroids), at Miami,
Fla. (S.D. Fla.); Civil Action No. 99-0912.
CHARGED 3-30-99: While held for sale after shipment in interstate commerce at Fontastic Products, Inc., in Miami, Fla., the articles were misbranded in that their labels failed to bear adequate directions for use and they were not exempt from such requirement under 21 C.F.R. Section 201.115, since the articles were unapproved new drugs--502(f)(1); and that they had not been duly listed as required by 21 U.S.C. Section 360(i)--502(o). The articles were further misbranded in that their labels failed to bear, at a minimum, the symbol "Rx Only."--503(b)(4)(A).
DISPOSITION: Pursuant to a final default judgement entered on July 26 1999, the articles of drug were destroyed. (F.D.C. No. 67206; S. No. 41113; S.J. No. 4)
ACTION: Mylan Pharmaceuticals, Inc. v. Shalala, at Washington,
D.C. (D. D.C.); Civil Action No. 1:99CV02995.
CHARGED 11-10-99: This action challenged the Food and Drug Administration's refusal to grant immediate approval of Mylan's abbreviated new drug application No. 75-140 to market pharmaceutical products containing terazosin hydrochloride as generic versions of HYTRIN capsules, marketed by Abbott Laboratories, Inc.
DISPOSITION: On January 4, 2000, Judge Richard W. Roberts declared invalid 21 C.F.R. Section 314.107(e), an FDA regulation defining "court" in 21 U.S.C. Section 355(j)(5)(B)(iv) to the "the court that enters final judgement from which no appeal can be or has been taken." At issue was what type of "court decision" could trigger the start of a 180-day period of exclusivity for the first generic drug applicant to assume the risk of patent litigation. FDA argued that the statutory reference to "court" was ambiguous so the agency had discretion to define the term as it did in its regulation.
The Court disagreed, finding that FDA "confuse[d] generality for ambiguity" and promulgated an unduly narrow interpretation of a clear statutory term. Although the Court declared FDA's regulation invalid, it refused to grant Mylan the relief it requested--immediate approval of its drug--because it found that Mylan's competitor relied in good faith on the FDA regulation it thought to be valid. FDA has not determined whether it will recommend appeal of this decision. (Misc. 1235; S.J. No. 5)
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