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: Canned tomatoes, canned peach slices, and canned grapefruit, two seizure actions, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-93-4917.
CHARGED 10-29-93: All of the articles were exported from Canada as part of a salvage lot from a bankruptcy sale and were held at Federation Warehouse in New York, N.Y. The tomatoes were adulterated in that they were contained in dented, rusted, swollen, and leaking cans--402(a)(3); the peaches contained Geotrichum mold and were misbranded in that the labels expressed the net quantity of contents in terms of fluid measure rather than in terms of weight measure--402(a)(3) and 403(f). The grapefruit contained developed seeds, and the peaches contained pit fragments in excess amount of the applicable standard--403(h)(1).
DISPOSITION: Default--articles destroyed. (F.D.C. 66764 and 66712; S. Nos. 92-508-941 and 92-508-948; S.J. No. 1)

PRODUCT: Crab meat, frozen, at Philadelphia, Pa. (E.D.Pa.); Civil No. 87-6155.
CHARGED 9-30-87: While held at Blue Grass Distribution Center in Philadelphia, Pa., the article was adulterated after interstate shipment in that the food contained Listeria monocytogenes--402(a)(1); the article was prepared, packed and held under insanitary conditions where the food was contaminated with Escherichia coli--402(a)(4); the article was misbranded in that the labeling of many of the cartons incorrectly identified the product as frozen shrimp instead of frozen crab meat--403(b); and the label failed to state the name and place of business of the manufacturer, packer or distributor--403(e).
DISPOSITION: Default--article destroyed. (F.D.C. 65261; S. No. 87-441-827; S.J. No. 2)

PRODUCT: Lobster meat, frozen, at Chicago, Ill. (N.D.Ill.); Civil No. 91C703.
CHARGED 7-26-91: While at Americold Corporation in Chicago, Ill., the article was adulterated in that it consisted in part of a decomposed substance--402(a)(3).
DISPOSITION: Default--article destroyed. (F.D.C. 66218; S. No. 91-575-999; S.J. No. 3)

PRODUCT: Sturgeon in tomato sauce, perch-pike, stuffed eggplant in tomato sauce, and stellated sturgeon low-acid canned foods, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-92 4967.
CHARGED 10-20-92: While held for sale at M & A International, Inc., in Brooklyn, N.Y., the articles were adulterated in that they were prepared and packed under conditions which might have rendered them injurious to health due to inadequate processing--402(a)(4); the perch-pike, eggplant in tomato sauce, and stellated sturgeon were misbranded before and after interstate shipment in that they were in package form and failed to bear labels containing the name and place of business of the manufacturer, packer or distributor--403(e)(1); the label of the eggplant in tomato sauce did not appear in English, and the labels of the stuffed eggplant and eggplant in tomato sauce were not expressed in terms of weight--403(f); the label for the perch-pike failed to identify the food by its common or usual name--403(i)(1); and all of the articles were made from two or more ingredients that were not listed on the labels by their common or usual names--403(i)(2).
DISPOSITION: Decree--articles destroyed. (F.D.C. 66462; S. No. 92-638-500; S.J. No. 4)

PRODUCT: White fragrant rice, at Los Angeles, Calif. (C.D.Calif.); Civil No. 89 7136.
CHARGED 12-11-89: While held for sale at PFC Foods, Inc., in Los Angeles, Calif., the article was adulterated in that it had been held under insanitary conditions where it might have become contaminated with filth--402(a)(4); and the article contained insects, insect pupae, insect larvae, and insect skins--402(a)(3).
DISPOSITION: A consent decree of condemnation released the article to the claimant, who voluntarily destroyed and reconditioned parts of the article. (F.D.C. 65787; S. No. 90-556-488; S.J. No. 5)

Drugs/Human Use

PRODUCT: Amaphen with codeine No. 3 capsules, at Pittsburgh, Pa. (W.D.Pa.); Civil No. 86-1364.
CHARGED 6-26-86: While held after interstate shipment at Trimen Laboratories, Inc., in Pittsburgh, Pa., the articles were new drugs without an approved new drug application--505(a) and (b).
DISPOSITION: A summary judgment ordered the articles destroyed. (F.D.C. 64732; S. No. 85-419-342; S.J. No. 6)

PRODUCT: Colon Cleanser, Liv-Flush, Kidney Flush, Arthritis Nutrient Formula, Prostate Plus, Cata-Rx, and Aloe/Cranberry Flush, at Long Island City, N.Y. (E.D.N.Y.); Civil No. CV-91-4802.
CHARGED 12-4-91: While held after interstate shipment at L&H Vitamins, Inc., in Long Island City, N.Y., the articles were new drugs without an approved new drug application--505(a) and (b).
DISPOSITION: A decree of forfeiture ordered the articles destroyed. (F.D.C. 65955; S. No. 90-626-621; S.J. No. 7)

PRODUCT: Hauck G-2 and G-3 capsules, at Alpharetta, Ga. (N.D.Ga.); Civil No. 86-1305A.
CHARGED 6-10-86: While held after interstate shipment at W.E. Hauck, Inc., in Alpharetta, Ga., the articles were new drugs without an approved new drug application--505(a) and (b); and the articles were misbranded in that their labeling failed to give adequate directions for use--502(f)(1).
DISPOSITION: A summary judgment ordered the articles forfeited and condemned. The articles were destroyed. (F.D.C. 64698; S. No. 82-482-515/516; S.J. No. 8)

PRODUCT: Liv-Flush, PressuRest, ProZaine, Kidney Flush, Heart-Ex, ChromMate, Blood Cleanser, Whole Dried Cranberry Fruit, Ester C., Bee Pollen, Kyolic, and PROZ Personal Oxygen System, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-91-4802.
CHARGED 12-4-91: While held after interstate shipment at L&H Vitamins, Inc., in Long Island City, N.Y., the articles were new drugs without an approved new drug application--505(a) and (b); the articles were misbranded while held for sale after shipment in that their labeling was false and misleading since they represented and suggested that the articles were safe and effective for their intended use--502(a); and the articles' labeling failed to bear adequate directions for use--502(f)(1). The Personal Oxygen System was misbranded while held for sale after shipment of one or more of its components--503(b)(4).
DISPOSITION: A portion of the articles was seized on 12-23-91. A consent decree ordered the seized drugs condemned, forfeited and destroyed. Regarding the drugs that were not seized, the claimant affirmed they did not fill any orders after 12-23-91, they returned any monies received for such orders, and they returned to the vendors the articles it had in stock or which it might have subsequently received. Furthermore, the claimant informed the vendors that the government considered the articles unlawful. The claimant destroyed any remaining articles. (F.D.C. 66060; S. No. 90-600-481; S.J. No. 9)

PRODUCT: Margensic No. 3 tablets, at Lafayette, La. (W.D.La.); Civil No. 86-1353.
CHARGED 5-29-87: While held after interstate shipment at Marnel Pharmaceuticals, Inc., in Lafayette, La., the articles were new drugs without an approved new drug application--505(a) and (b).
DISPOSITION: A summary judgment ordered the articles destroyed. (F.D.C. 64695; S. No. 85-314-085; S.J. No. 10)

Drugs/Veterinary

PRODUCT: Prozyme enzymatic protein supplement, at Kansas City, Mo. (N.D.Mo.); Civil No. 91-0595-CV-W-8.
CHARGED on or about 7-2-91: While held for sale after interstate shipment at Veterinary Companies of America, Inc., in Kansas City, Mo., the article was adulterated in that it was an unsafe, new animal drug without an approved new drug application--501(a)(5); and the article was misbranded in that its labels failed to bear adequate directions for use--502(f)(1).
DISPOSITION: Default--article destroyed. (F.D.C. 66159; S. No. 90-596-962; S.J. No. 11)

Medical Devices

PRODUCT: Lithotriptor Spark Plugs, at Frederick, Md. (D.Md.); Civil No. B-92-1849.
CHARGED 7-1-92: While held at Frederick Self Storage, in Frederick, Md., the articles were adulterated in that they were class III devices that did not have an application for premarket approval--501(f)(1)(B); and the articles were misbranded in that the labeling failed to bear adequate directions for use, and they were not manufactured in a registered establishment--502(f)(1) and 502(o). DISPOSITION: A default decree of forfeiture condemned the articles, forfeited the rights and interests of the manufacturer, and ordered the articles destroyed. (F.D.C. 66430; S. No. 92-516-233; S.J. No. 12)

CRIMINAL ACTIONS

DEFENDANTS: Par Pharmaceuticals, Inc., at Baltimore, Md. (D.Md.); Criminal No. HAR-91-0433.
CHARGED 12-6-91 by grand jury: Count 1: The defendant adulterated the drug Cloridine HCl in that it manufactured and processed the drug using methods and controls that did not conform to good manufacturing practices--301(a) and 303(a)(2); Count 2: The defendant shipped in interstate commerce the generic drug megestrol acetate, which was adulterated in that the employees prepared and maintained false product batch records and manufactured the drug by adding an ingredient that was not included in the approved formula--301(a) and 303(a)(2).
Counts 3-8: The defendant made false statements to FDA by (a) failing to accurately state the manner, order and instructions by which the drug thioridazine was milled and mixed, (b) failing to correctly show where the drug haloperidol was produced, (c) misrepresenting the batch size of the drug leucovorin calcium, (d) misrepresenting the batch and proportion size of lactose anhydrous NF, Starch 1500, povidone USP, Aerosil 200, stearic acid NF, zinc stearate, Green Caffine Granulation with Starch, and Orphengesic Forte, (e) falsely creating batch records of the drug methyldopa that did not reflect the unapproved addition of magnesium stearate, and f) recreating batch records, falsifying accelerated stability data, and laboratory reports of the generic drug triameterene/hydrochlorothiazide--18 U.S.C. 1001.
Count 9: The defendant influenced, obstructed and impeded an inspection of its drug manufacturing facility in that its agents and employees falsely represented a batch of tablets to an FDA investigator in order to conceal the fact that the batch did not contain sodium bicarbonate and the fact that the product had not been submitted for bioequivalency testing--18 U.S.C. 1505.
Count 10: The defendant adulterated the drug Tolazamide in that it failed to comply with good manufacturing practices, by preparing and maintaining false batch records--301(k) and 303(a)(2).
DISPOSITION: Guilty plea; a $2,500,00 cumulative fine and a special assessment of $200 for each of the 10 counts. (F.D.C. 65712; S.J. No. 13)

DEFENDANT: Padam Bansal, director of research and development, Baltimore, Md. (D.Md.); Criminal No. HAR-92-066.
CHARGED 3-19-93 by grand jury: In connection with Par Pharmaceuticals, Inc., defendant was charged with obstructing an FDA investigation by giving false and misleading testimony to the grand jury regarding the batch record for the drug triameterene/hydrochlorothiazide--18 U.S.C. 1503.
DISPOSITION: Guilty plea; two years' probation, sentenced to six months home confinement, and ordered to pay a $50 special assessment. (F.D.C. 66533; S.J. No. 14)

DEFENDANTS: Edward Boden Sr., Edward Boden Jr., and Roger Walsh Jr., Chicago, Ill. (N.D.Ill.); Civil Nos. 89 CR 645-1; 89 CR 645-2, and 89 CR 645-3.
CHARGED 2-23-90 and 3-2-90 by a grand jury: Conspiracy by the three defendants to increase the sales and profits of Bodine's Inc., and their salaries by falsely representing that low-cost adulterated and misbranded products manufactured and sold by Bodine's Inc. were 100 percent pure orange juice products--301(a) and (k), and 303(b). Foods labeled as orange juice, orange juice from concentrate, and frozen concentrated orange juice were adulterated in that the orange juice and orange juice concentrate were omitted from the product and substituted with inferior and cheaper ingredients--402(b)(1) and 402(b)(2).
DISPOSITION: Guilty pleas; Edward Boden Sr. was sentenced to two years in prison, a $250,000 fine, 1,000 hours of community service, five years' probation, and a special assessment of $150. Edward Boden Jr. was sentenced to two years' probation, a $200,000 fine, 200 hours of community service, and a special assessment of $125. Roger Walsh Jr. was sentenced to two years' probation and 200 hours of community service. (F.D.C. 64573, S. No. 85-499-315; S.J. No. 15)

DEFENDANT: John Sadlon, vice president of operations, Baltimore, Md. (D.Md.); Criminal No. HAR-92-0336.
CHARGED 6-21-95 by grand jury: In connection with Par Pharmaceuticals, Inc., defendant was charged with aiding and abetting in the interstate shipment and adulteration of the drug methyldopa in that it did not conform to good manufacturing practices--301(k) and 303(h).
DISPOSITION: Guilty plea; ordered to pay a $3,000 fine and a $50 special assessment; two years' probation and 500 hours of community service. (F.D.C. 66560; S.J. No. 16)

DEFENDANT: Atul Shah, director of analytical research and developmental laboratory, Baltimore, Md. (D.Md.); Criminal No. HAR-92-0337.
CHARGED 3-5-93 by grand jury: In connection with Par Pharmaceuticals, Inc., defendant was charged with making false statements to the grand jury regarding the pilot batch of the drug triameterene/hydrochlorothiazide.
DISPOSITION: Guilty plea; two years' probation and ordered to pay a $50 special assessment. (F.D.C. 66561; S.J. No. 17)

FDA Consumer magazine (July-August 1995)