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 Food and Drug Division, Office of the General Counsel, HHS, and are published by direction of the Secretary of Health and Human Services.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Cocktail shrimp, at Port Newark, N.J. (D. N.J.); Civil Action No. 91-3990.
CHARGED 9-13-91: While held for sale after shipment in interstate commerce at Port Newark Refrigerated Warehouse, in Port Newark, N.J., the articles were misbranded in that the package failed to bear a label containing an accurate statement of the net quantity of contents--403(e)(2).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66254; S.J. No. 91-643-384; S.J. No. 1)

PRODUCT: Infant formula, at Orlando, Fla. (M.D. Fla.); Civil Action No. 96-182-CIV-ORL-19.
CHARGED 2-20-96: While held for sale after shipment in interstate commerce at 4C Transportation Warehouse, in Orlando, Fla., the articles were adulterated in that they were not processed in compliance with current good manufacturing practice requirements because the containers failed to bear lot codes--412(a)(3). The articles were misbranded in that the labels failed to bear a declaration of the nutrients in the order given and the unit specified and a statement of the number of fluid ounces supplying 100 kilocalories. The labels also failed to bear a statement of the amount of each nutrient supplied by 100 kilocalories and directions for use that contain the weight and volume of powdered formula to be reconstituted--403(j).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67128; S. No. 96-712-384; S.J. No. 2)

PRODUCT: Milk, evaporated, at Angola, La. (M.D. La.); Civil Action No. 96-3331-B-2.
CHARGED 8-1-96: While held for sale at Louisiana State Penitentiary, in Angola, La., after shipment in interstate commerce, the articles were adulterated in that they were unfit for food because the cans of milk were heavily rusted and dented, and they were held under insanitary conditions whereby they might have become contaminated with filth--402(a)(3) and 402(a)(4).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67145; S. No. 96-690-738; S.J. No. 3)

Drugs/Human Use

PRODUCT: Oxygen, at Mesa and Phoenix, Ariz. (D. Ariz.); Civil Action No. Civ-90-0805 PHX PGR.
CHARGED 5-29-90: While held for sale after shipment in interstate commerce at Apollo Medical, Inc., in Mesa and Phoenix, Ariz., the articles were adulterated in that the methods used in and the facilities and controls used for their manufacture, processing, packaging, and holding were not in conformity with current good manufacturing practice requirements--501(a)(2)(B).
DISPOSITION: A consent decree of condemnation was filed. Subsequently, the company declared bankruptcy and went out of business. The articles were seized and sold at auction. (F.D.C. No. 65858; S. No. 90-567-953; S.J. No. 4)

PRODUCT: Oxygen, at Pocatello, Idaho (D. Idaho); Civil Action No. CIV 94-0340-E-HLR.
CHARGED 8-3-94: While held for sale after shipment in interstate commerce at Maag Prescription & Medical Supply, Inc., in Pocatello, Idaho, the articles were adulterated in that the methods used in, and the facilities and controls used for, their manufacture, processing, packing, and holding were not in conformity with current good manufacturing practice requirements--501(a)(2)(B).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 66933; S. No. 94-628-683; S.J. No. 5)

Medical Devices

PRODUCT: In vitro diagnostic products, at Loganville, Ga. (M.D. Ga.); Civil Action No. 3:95-CV-27-DF.
CHARGED 3-7-95: While held for sale after shipment in interstate commerce at Roach Laboratories, Inc., in Loganville, Ga., the articles were adulterated in that they were class III devices without an application for premarket approval--501(f)(1)(B). The articles were also adulterated in that the methods used in, and the facilities and controls used for, their manufacture, packing and storage were not in conformity with current good manufacturing practice requirements--501(h).
DISPOSITION: The articles were donated to the Centers for Disease Control and Prevention. Subsequently, the firm ceased doing business, and the claimant filed a voluntary dismissal. (F.D.C. No. 66912; S. No. 93-654-171; S.J. No. 6)

CRIMINAL ACTIONS

DEFENDANT: New England Shrimp Company and G. Robert Randazzo, at Ayer, Mass. (D. Mass.); Criminal No. 94-10039-RWZ.
CHARGED 10-28-94: Count 1: The defendants knowingly conspired to conceal that shrimp supplied by the New England Shrimp Company (NESC) contained tripolyphosphates (STPs), which were prohibited by contracts with several federal government agencies--18 U.S.C. section 1001. The defendants also knowingly conspired to make fraudulent claims for payment against several federal government agencies by submitting invoices where the shrimp failed to meet contract requirements--18 U.S.C. section 287. The defendants, with the intent to defraud, conspired to obstruct a federal auditor from performing quality assurance inspections of shrimp relating to contracts under which NESC received in excess of &100,000 in a one-year period--18 U.S.C. section 1516.
Counts 2 to 51: The defendants knowingly made fraudulent claims for payment against the United States by submitting invoices for shrimp that did not meet the contract requirements--18 U.S.C. sections 287 and 2.
Count 52: The defendants, with the intent to defraud, conspired to introduce into interstate commerce shrimp adulterated with saccharin, an unsafe food additive--301(a) and 303(a)(2). The defendants, with the intent to defraud, also conspired to add saccharin to shrimp while the shrimp was held for sale after shipment in interstate commerce--301(k) and 303(a)(2).
Counts 53 to 64: The defendants, with the intent to defraud, knowingly introduced into interstate commerce adulterated shrimp--301(a) and 303(a)(2), 18 U.S.C. section 2.
Count 65: The defendants, with the intent to defraud, conspired to introduce into interstate commerce misbranded shrimp. The shrimp was misbranded in that its labeling failed to disclose that the shrimp had been colored with sodium hydroxide, and it failed to list the common or usual name for one of the ingredients from which the shrimp had been fabricated. The labeling also falsely represented that the shrimp was from the United States when, in fact, it was from China--301(a) and 303(a)(2). The defendants, with the intent to defraud, conspired to misbrand shrimp while it was held for sale after shipment in interstate commerce--301(k) and 303(a)(2). The defendants also conspired to falsely state that the shrimp was from the United States when, in fact, it was from China--18 U.S.C. section 1001.
Counts 66 to 78: The defendants, with the intent to defraud, introduced into interstate commerce shrimp that was misbranded in that its labeling failed to disclose that the shrimp was colored with sodium hydroxide. The labeling also failed to list the common or usual name for one of the ingredients from which the shrimp food was fabricated, namely sodium hydroxide, or designate such an ingredient as coloring. The shrimp was also misbranded in that its labeling falsely represented that the shrimp was from the United States when, in fact, it was from China--301(a) and 303(a)(2), 18 U.S.C. section 2.
Count 79: The defendants, with the intent to defraud, conspired to introduce into interstate commerce frozen raw breaded shrimp that was misbranded in that the shrimp represented a food for which a standard of identity was prescribed by regulation, but it did not conform to such standard of identity because it contained STPs, which were not permitted by the standard--301(a) and (k) and 303(a)(2), 18 U.S.C. section 371.
Counts 80 to 97: The defendants, with the intent to defraud, introduced into interstate commerce frozen raw breaded shrimp that was misbranded in that it was represented to be a food for which a standard of identity was prescribed by regulation, but did not conform to such standard because it contained STPs, which were not permitted by regulation--301(a) and 303(a)(2), 18 U.S.C. section 2.
Counts 98 to 101: Defendant Robert Randazzo willfully filed a Corporate Income Tax Return Form for NESC in which he overstated the cost of purchases made by the company when he knew that the amount filed was not the true cost of purchases. Randazzo also overstated the amount paid to employees for work performed by including an amount he knew was not truly the salary of an employee--18 U.S.C. section 2, 26 U.S.C. section 7206(1).
DISPOSITION: The New England Shrimp Company was sentenced to pay a nominal fine after the court determined that it no longer had substantial assets. Defendant Robert Randazzo, who was found guilty on all counts, was sentenced to three years of imprisonment and two years of supervised release, and was ordered to pay a $5,050 assessment. Randazzo appealed his conviction, but the Court of Appeals upheld the district court's ruling. (F.D.C. No. 66479; S.J. No. 7)

DEFENDANT: Ortho Pharmaceutical Corp., at Raritan, N.J. (D. N.J.); Criminal No. 95-12 (WGB).
CHARGED 1-11-95: Count 1: The defendant knowingly conspired to impede a federal grand jury investigation--18 U.S.C. section 371.
Count 2: The defendant knowingly obstructed a federal grand jury investigation in that employees under the direction of high-ranking representatives shredded documents and other records responsive to the grand jury subpoena--18 U.S.C. sections 1503 and 2.
Counts 3 to 10: The defendant corruptly persuaded individuals to destroy documents and other objects for use in an official investigation conducted by federal agencies--18 U.S.C. sections 1512(b)(2)(B) and 2.
DISPOSITION: The defendant pleaded guilty to all counts and was ordered to pay a $5 million fine and $2.5 million in restitution. (F.D.C. No. 65986; S.J. No. 8)

INJUNCTION ACTIONS

DEFENDANT: Enzymatic Therapy, Inc., Terence Lemerond, and Bradley Lemerond, at Green Bay, Wis. (E.D. Wis.); Civil Action No. 91-C-1174.
CHARGED 11-5-91: The defendants introduced into interstate commerce misbranded and unapproved new drugs--301(a) and 301(d). The articles were misbranded in that their labeling failed to bear adequate directions for their intended use--502(f)(1).
DISPOSITION: The articles were reconditioned. (Inj. No. 1232; S. No. 89-528-927; S.J. No. 9)

MISCELLANEOUS ACTIONS

ACTION: Barnes et al. v. Shalala, at Verona, Wis. (W.D. Wis.); Civil Action No. 94C-0090C.
CHARGED 2-3-94: The plaintiffs alleged that the defendant violated the Federal Food, Drug, and Cosmetic Act, the National Environmental Policy Act, and the Administrative Procedure Act in approving the use of the synthetic bovine growth hormone (rBGH)--also referred to as bovine somatotropin (bST)--to increase milk production in cows.
DISPOSITION: The defendant filed a motion to dismiss, and several plaintiffs were dismissed for lack of standing. The case was resolved in the agency's favor on summary judgment. An appeal was not filed. (Misc. No. 1012; S.J. No. 10)

FDA Consumer magazine (March 1997)