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: Cumin seeds, at Jamaica, N.Y. (E.D.N.Y.); Civil No. CV-95-4855.
CHARGED 11-27-95: While held for sale after shipment in interstate commerce at William E. Martin & Sons Company, Inc., in Jamaica, N.Y., the articles were adulterated in that they consisted of a filthy substance, rodent urine--402(a)(3).
DISPOSITION: A decree of condemnation ordered the articles destroyed. (F.D.C. No. 67113; S. No. 95-782-274; S.J. No. 1)

PRODUCT: Mushrooms, at Bayonne, N.J. (D.N.J.); Civil No. 95-2793 (JWB).
CHARGED 6-14-95: While held for sale after shipment in interstate commerce at Railhead Warehouse in Bayonne, N.J., the articles were adulterated in that they contained a poisonous and deleterious substance which might have rendered them injurious to health--402(a)(1). The articles were unfit for food in that they were contained in swollen and leaking cans, and they were prepared and packed under conditions whereby they might have been rendered injurious to health--402(a)(3) and (a)(4).
DISPOSITION: A default judgment and final order of forfeiture ordered the articles destroyed. (F.D.C. No. 67089; S. No. 1985607; S.J. No. 2)

PRODUCT: Peppers, dried, at Chicago, Ill. (N.D. Ill.); Civil No. 94-C-00900.
CHARGED: 2-11-94: While held for sale after shipment in interstate commerce at La Hacienda Brands, Inc., in Chicago, Ill., the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: A consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 66929; S. No. 94-710-098/9; S.J. No. 3)

PRODUCT: Porcelain food service articles, at San Francisco, Calif. (N.D. Calif.); Civil No. C-93-0439 (JPV).
CHARGED 2-5-93: While held for sale after shipment in interstate commerce at Wing Sing Chong Company, Inc., in San Francisco, Calif., the articles were adulterated in that they contained lead, an unsafe food additive--402(a)(2)(C).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66651; S. No. 92-706-261; S.J. No. 4)

PRODUCT: Scallops, at Hanover, Pa. (M.D. Pa.); Civil No. 1:CV-95-0232.
CHARGED 2-15-95: While held for sale after shipment in interstate commerce at Hanover Cold Storage, Inc., in Hanover, Pa., the articles were adulterated in that they consisted of decomposed scallops--402(a)(3).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 67063; S. No. 95-693-660; S.J. No. 5)

PRODUCT: Shrimp, frozen, at Brownsville, Texas (S.D. Texas); Civil No. H-95-3399.
CHARGED 6-26-95: While held for sale after shipment in interstate commerce at Gulf Cold Storage, in Brownsville, Texas, the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: A default decree of forfeiture ordered the articles destroyed. (F.D.C. No. 67090; S. No. 95-666-542; S.J. No. 6)

PRODUCT: Various articles of food, at San Francisco, Calif. (N.D. Calif.); Civil No. C-93-3245 (SBA).
CHARGED 9-2-93: While held for sale after shipment in interstate commerce at Lop Sing Trading Company, in San Francisco, Calif., the articles were adulterated in that they contained unsafe food additives--402(a)(2)(C). The articles were also adulterated in that they contained filth, and they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(3) and 403(a)(4). The articles were misbranded in that their labeling was false and failed to reveal that the articles contained an ingredient that might have been hazardous--403(a)(1). The articles were also misbranded in that they failed to bear labeling stating the place of business of the manufacturer, packer or distributor, and they failed to bear labeling with an accurate statement of the quantity of contents in terms of weight, measure, or numerical count--403(e)(1) and 403(e)(2). The articles also failed to bear labeling containing the common or usual name of the food, and of two or more ingredients from which the articles were fabricated--403(i)(1) and 403(i)(2). The articles labeling failed to state that they contained a chemical preservative, and their labeling failed to bear a warning label regarding saccharin contained in the articles--403(k) and 403(o)(1).
DISPOSITION: A default decree of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66759; S. No. 93-449-929; S.J. No. 7)

PRODUCT: Wahoo fish fillets, frozen, at Charlotte, N.C. (W.D.N.C.); Civil No. 3:95CV-307-H.
CHARGED 7-26-95: While held for sale after shipment in interstate commerce at United Refrigerated Services in Charlotte, N.C., the articles were adulterated in that they consisted of decomposed fish--402(a)(3).
DISPOSITION: The articles were destroyed by the potential claimant. (F.D.C. No. 67091; S. No. 95-617-827; S.J. No. 8)

CRIMINAL ACTIONS

DEFENDANTS: Robert Cetrone, Gerald Seymour, Timothy Hyzy, Vicky Finney, Maria Paradise, Michelle Tynes Rauscher, Robert Thomson Jr., Luisito Sison, Jan Stankowicz, and Michael Walton, at South Bend, Ind. (N.D. Ind.); Criminal No. SCR 92-19.
CHARGED 6-11-92: Count 1: The defendants willfully conspired to tamper with implantable pacemaker pulse generators and cardiovascular permanent pacemaker electrodes by relabeling the devices with false make, model, serial numbers, and dates, selling expired devices for implanting, and implanting used devices--18 U.S.C. section 1365(a).
Count 2: Defendant Michael Walton tampered with devices by changing the validated date to a false use-before date--18 U.S.C sections 2 and 1365(a).
Count 3: Defendant Michael Walton tampered with the make, model, and serial number of a device that was implanted into a patient--18 U.S.C. section 1365(a).
Count 4: Defendant Michael Walton tampered with the use-before date on a device that was implanted into a patient--18 U.S.C. sections 2 and 1365(a).
Count 5: Defendant Michael Walton tampered with the labeling of a used device that was resterilized and implanted into a patient--18 U.S.C. sections 2 and 1365(a).
Count 6: Defendant Michael Walton sold a used pacemaker for implantation into a patient that was labeled "not for human implant" by the resterilization company--18 U.S.C. sections 2 and 1365(a).
Count 7: The defendants knowingly conspired to (a) obstruct FDA's regulatory authority, (b) pay unlawful gratuities to physicians regarding the sale of medical devices for which payment may be made under medicare, and (c) use the U.S. mails in a scheme to defraud--18 U.S.C. section 1341 and 42 U.S.C. section 1395y(h).
Count 8: Defendant Michael Walton devised a scheme to defraud various hospitals of money and property by knowingly making false and fraudulent representations regarding medical devices--18 U.S.C. sections 2 and 1341.
Count 9: Defendants Luisito Sison and Michael Walton, with the intent to defraud, knowingly caused an invoice for an accessory kit to be sent by U.S. mail to a hospital in Indiana--18 U.S.C. 1341.
Count 10: Defendant Michael Walton, with the intend to defraud, knowingly caused an invoice for a device to be sent by U.S. mail to a hospital in Indiana--18 U.S.C. section 1341.
Count 11: Defendant Michael Walton knowingly offered to pay for an all-expense-paid trip for a physician in order to induce him to purchase, order, and arrange for and recommend the purchase and order of pacemakers under the medicare program--42 U.S.C. section 1320a-7b(b)(2).
Count 12: Defendant Michael Walton possessed an embossing tool designed to make an impression of the seal of the State of Illinois with the intent of producing a false identification document--18 U.S.C. section 1028(a)(5).
Count 13: Defendant Michael Walton possessed an embossing tool designed to make an impression of the seal of the State of Indiana Board of Health with the intent of producing a false identification document--18 U.S.C. section 1028(a)(5).
DISPOSITION: Defendants Maria Paradise, Michelle Tynes Rauscher, Jan Stankowicz, Robert Cetrone, Timothy Hyzy, and Vicky Finney pleaded guilty to count 1. They were sentenced to one year of probation and were ordered to pay a $50 special assessment. Defendant Gerald Seymour pleaded guilty to counts 1 and 2. He was sentenced to one year of probation, and ordered to pay a $100 special assessment. Defendant Robert Thomson Jr. pleaded guilty to count 1 and was sentenced to one year of probation, and ordered to pay a $5,000 fine. Defendant Luisito Sison pleaded guilty to count 9. He was sentenced to two years of probation, and ordered to pay a $50 special assessment. Defendant Michael Walton pleaded guilty to all counts. He was sentenced to six years of prison and two years of probation. He appealed his conviction, but the appellate court affirmed. (F.D.C. No. 66137; S.J. No. 9)

INJUNCTION ACTIONS

DEFENDANTS: Kasz Enterprises, Inc., and James Kaszyk, at Warwick, R.I. (D.R.I.); Civil No. 93-0455P.
CHARGED 8-23-93: While held for sale at Kasz Enterprises in Warwick, R.I., the defendants introduced into interstate commerce unapproved new drugs--331(d). The articles were misbranded in that their labeling failed to bear adequate directions for use--352(f)(1). The defendants introduced into interstate commerce misbranded drugs--331(a).
DISPOSITION: The court issued an injunction restricting the defendants from introducing the articles into interstate commerce. (Inj No. 1318; S. No. 92-658-944/945; S.J. No. 10)

FDA Consumer magazine (June 1996)