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: Pure Egg Noodles, imported, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-95-0270.
CHARGED 1-19-95: While held for sale after shipment in interstate commerce at Beluga Caviar International Foods, Inc., in Brooklyn, N.Y., the articles were adulterated in that they consisted of rodent excreta and rodent hair, and they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(3) and 402(a)(4).
DISPOSITION: A final order and judgment on default ordered the articles destroyed. (F.D.C. No. 67038; S. No. 94-726-191; S.J. No. 1)

PRODUCT: Mushrooms, stems and pieces, at St. Cloud, Minn. (D.Minn.); Civil No. 3-94-1629.
CHARGED 1-27-95: While held for sale after shipment in interstate commerce at Cobarn's Inc., in St. Cloud, Minn., the articles were adulterated in that they contained staphylococcal enterotoxin, and they were prepared and packed under conditions which might have rendered them injurious to health--402(a)(1) and 402(a)(4).
DISPOSITION: A default decree of condemnation, forfeiture and destruction ordered the articles destroyed. (F.D.C. No. 67041; S. No. 94-742-475; S.J. No. 2)

PRODUCT: Tuna Loins, yellow fin, at Seattle, Wash. (W.D.Wash.); Civil No. C94-1745.
CHARGED 11-23-94: While held for sale after shipment into interstate commerce at Cityice Cold Storage Co., in Seattle, Wash., the articles were adulterated in that they consisted of decomposed fish--402(a)(3).
DISPOSITION: A consent decree of condemnation, forfeiture and destruction ordered the articles destroyed. (F.D.C. No. 67033; S. No. 95-737-665; S.J. No. 3)

Drugs/Human Use

PRODUCT: Aidex Antimicrobial Liquid Soap, Aidex Antimicrobial Cream, Aidex Antimicrobial Aqueous Lotion, and Aidex Spray Cleaner, at Jessup, Md. (D.Md.); Civil No. WN94-685.
CHARGED 3-18-94: This was a drug and device seizure. While held after shipment in interstate commerce at Service Warehouse and Distribution Co., Inc., in Jessup, Md., the articles were adulterated in that the Aidex spray cleaner contained mold and an insect, and it was a class III device without an approved application or investigational device exemption--501(a)(1) and 501(f)(1)(B). The Aidex antimicrobial liquid soap and aqueous lotion were non-compendial drugs whose strengths differed from what they were represented to possess, and their labeling falsely represented that they contained resorcinol--501(c) and 502(a). The drugs failed to bear labeling containing adequate directions for their intended purposes--502(f)(1). Information or notice regarding the device was not provided at least 90 days prior to their introduction into interstate commerce--502(o).
DISPOSITION: A stipulated order of condemnation and destruction ordered the articles destroyed. (F.D.C. No. 66791; S. No. 93-623-9229; S.J. No. 4)

PRODUCT: Oxycodone and Aspirin, tablets, at Brooklyn, N.Y. (E.D.N.Y.); Civil No. CV-93-2899.
CHARGED 6-30-93: While held for sale after shipment in interstate commerce at Halsey Drug Co., Inc., in Brooklyn, N.Y., 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 requirements--501(a)(2)(B).
DISPOSITION: A consent decree ordered the articles destroyed. (F.D.C. No. 66735; S. No. 93-726-092; S.J. No. 5)

CRIMINAL ACTIONS

DEFENDANTS: Quad Pharmaceuticals et al., at Indianapolis, Ind. (D.Md.); Criminal No. 93-HAR-0147.
CHARGED 9-30-93: Count 1: The defendants, willfully and knowingly, (a) made false statements and representations in matters within the jurisdiction of FDA; (b) concealed material facts from FDA; (c) failed, with intent to defraud, to establish and maintain required records; (d) manufactured and introduced adulterated and misbranded generic drug products into interstate commerce; and (e) corruptly influenced the administration of law--18 U.S.C. section 371.
Count 2: Defendant Dilip Shah, knowingly and willfully, made a material false statement and representation to FDA in that he submitted separate batch production records for a generic drug and stated that the batch records reflected the manufacture by Quad of "two separate 10-liter production batches" of the product, when only one 10-liter batch was manufactured and was reprocessed so that it would appear that multiple batches were manufactured--18 U.S.C. sections 2 and 1001.
Count 3: Defendants Dilip Shah and Raja Feroz, knowingly and willfully, made a material false statement and representation to the FDA in that they sent an annual report to FDA stating that in Quad's production of a generic drug there were no changes to the manufacturing and control of the drug that had not been already submitted and approved as a supplemental application, when in fact Quad manufactured the product using more anti-oxidant than was specified in the FDA-approved master formula--18 U.S.C. sections 2 and 1001.
Count 4: Defendants Dilip Shah and Arun Kumar, knowingly and willfully, concealed from FDA inspectors the existence of certain drug product complaints, which are written records that must be maintained and made readily available for inspection by FDA--18 U.S.C. sections 2 and 1001.
Counts 5-6: Defendants Raja Feroz, Arun Kumar, and Asad Ullah, with the intent to defraud, introduced into interstate commerce quantities of a generic drug which were adulterated in that the batch production records were required to include complete information regarding the identity and quantity of all components and materials used in the manufacturing process and the results of all laboratory tests performed on the drugs; however, the batch production records failed to disclose either the addition of a residue into the batch of a previously manufactured batch of the same product or the results of laboratory tests performed on the residue prior to its addition--301(a), 303(a)(2), and 18 U.S.C. section 2.
DISPOSITION: Dilip Shah pleaded guilty to one count of making a false statement to FDA. He was sentenced to 46 months in prison and fined $15,000. Dulal Chatterji pleaded guilty to two felony counts, one count of obstructing a federal agency proceeding, and one count of conspiring to defraud an agency of the United States. He was sentenced to 30 months in prison and fined $100. Jan T. Strum pleaded guilty to concealing material facts from FDA. He was sentenced to six months of electronically monitored home confinement and fined $2,500. Andrew Morris pleaded guilty to conspiring to defraud FDA and obstruction. He was sentenced to 10 months in prison and fined $3,000. Arun Kumar pleaded guilty to aiding and abetting the introduction into interstate commerce of adulterated drug products with the intent to defraud. He was sentenced to four months in prison and four months home detention. (F.D.C. No. 65984; S.J. No. 6)

DEFENDANT: Jesus Rodriguez, d/b/a Farmacia de Watto, at Canovanas, Puerto Rico (D.Puerto Rico); Criminal No. 94-040(RLA).
CHARGED 2-4-94: The defendant knowingly sold and offered to sell a prescription drug that was clearly labeled "Sample--Not for Sale"--301(t) and 303(b).
DISPOSITION: Guilty plea; sentenced to one year's probation and ordered to pay a $50 special assessment. (F.D.C. No. 66548; S. No. 91-633-596; S.J. No. 7)

DEFENDANT: Symbion, Inc., at Salt Lake City, Utah (C.D.Utah); Criminal No. 94-CR-088G.
CHARGED 6-6-94: The defendant obtained investigational device exemptions ("IDEs") for its Total Artificial Heart and Acute Ventricular Assist Device. As the sponsor of the IDEs, the defendant was required to monitor the investigations and submit annual reports to FDA. The defendant submitted an annual report which falsely represented that Symbion fulfilled its own procedure and performed on-site monitoring visits to the sites participating in the IDE studies--301(g) and 510j(g).
DISPOSITION: Guilty plea; fined $200,000 and ordered to pay a $250 special assessment. (F.D.C. No. 65990; S. No. 90-486-276; S.J. No. 8)

INJUNCTION ACTIONS

DEFENDANTS: Advance Medical Designs, Inc., Thomas E. Cottone Jr., Ronald D. Arken, and Joseph R. Cottone Sr., at Marietta, Ga. (N.D.Ga.); Civil No. 1-93-CV-2970.
CHARGED 12-27-93: While held for sale at Advance Medical Designs, Inc., in Marietta, Ga., the sterile equipment covers and transfer/decanting devices were 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 regulations--501(h). The devices were also adulterated in that their purity and quality fell below that which they purported to possess because they were labeled "sterile" when they were not subjected to an adequate sterilization process--501(c). The devices were misbranded in that their labels were false and misleading because the devices were labeled as "sterile" when they were not subjected to an adequate sterilization process--502(a). The devices were also misbranded because they were dangerous when used in the manner recommended or suggested in their labeling because the devices are labeled as "sterile" when they were not subjected to an adequate sterilization process--502(j). The defendants introduced or caused to be introduced into interstate commerce the adulterated and misbranded devices--301(a).
DISPOSITION: A consent decree of permanent injunction was filed, and the defendants came into compliance with the decree. (Inj. No. 1330; S. No. 93-617-912; S.J. No. 9)

MISCELLANEOUS

ACTION: Back Technologies, Inc. v. Donna Shalala et al., at Everett, Wash. (D.D.C); Civil No. 1:94CV02247.
CHARGED 10-19-94: Back Technologies, Inc., manufactured and marketed the BACKTECH Back Machine, which claimed to relieve back and neck pain. The device was not approved by FDA. FDA requested the company stop marketing the exercise machine and submit the necessary applications for approval. The firm failed to file a premarket approval application or a premarket notification, yet continued to market the product--510e(a) and 510(k).
DISPOSITION: A memorandum opinion denied the plaintiff's request for declaratory relief and granted the defendant's motion for summary judgment. The plaintiff decided not to appeal the decision and will see that future advertising and labeling for the product conforms with FDA's requirements. (Misc. No. 1069, S.J. No. 10)

FDA Consumer magazine (November 1995)