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: Rice, at Houston, Texas (S.D. Texas); Civil Action No. H-96-1425.
CHARGED 5-3-96: While held for sale after shipment in interstate commerce at Captain Charlie Seafood Co., in Houston, Texas, the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67140; S. No. 96-730-121; S.J. No. 1

PRODUCT: Rice, long grain, at Washington, D.C. (D.D.C.); Civil Action No. 1:96CV00519.
CHARGED 3-15-96: While held for sale after shipment in interstate commerce at Happy Valley Food, Inc., in northeast Washington, D.C., the articles were adulterated in that they were held under insanitary conditions whereby they might have been contaminated with filth--402(a)(4).
DISPOSITION: The articles were reconditioned. (F.D.C. No. 67132; S. No. 96-655-220; S.J. No. 2

PRODUCT: Shrimp, frozen, at Tampa, Fla. (M.D. Fla.); Civil Action No. 94-1131-CIV-T-17C.
CHARGED 9-19-94: While held for sale after shipment in interstate commerce at Americold Cold Storage in Tampa, Fla., the articles were adulterated in that they consisted of decomposed shrimp--402(a)(3).
DISPOSITION: The shrimp were reconditioned into fish bait. (F.D.C. No. 66994; S. No. 94-557-490; S.J. No. 3

PRODUCT: Vegetarian mix, at Niles, Ill. (N.D. Ill.); Civil Action No. 94C-6103.
CHARGED 10-7-94: While held for sale after shipment in interstate commerce at International Golden Foods, Inc., in Niles, 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: The articles were destroyed. (F.D.C. No. 67026; S. No. 94-741-152; S.J. No. 4

Drugs/Human Use

PRODUCT: Acne cream, at Wallingford, Conn. (D. Conn.); Civil Action No. 394CV00813.
CHARGED 5-19-94: While held for sale after shipment in interstate commerce at Low Pharmaceuticals, Inc., in Wallingford, Conn., the articles were adulterated in that they were new drugs without an approved application--505(a). The articles were misbranded in that their labeling failed to bear the established name of each active ingredient and the directions for use--502(e) and 502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66787; S. No. 93-660-001; S.J. No. 5

PRODUCT: Various articles of drugs, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-96-1689.
CHARGED 4-9-96: While held for sale after shipment in interstate commerce at Maxi International Trading Corp., in Brooklyn, N.Y., the articles were adulterated in that they were new drugs without an approved application--505(a). The articles were misbranded in that their labeling failed to bear adequate directions for use--502(f)(1).
DISPOSITION: The articles were destroyed. (F.D.C. No. 67122; S. No. 95-646-441; S.J. No. 6

Medical Devices

PRODUCT: Stimulator, at Akron, Ohio (N.D. Ohio); Civil Action No. 5:95CV959.
CHARGED 4-28-95: While held for sale after shipment in interstate commerce at Universal Management Services, Inc., in Akron, Ohio, the article was adulterated in that it was a class III device without an application for premarket approval--501(f)(1)(B). The article was misbranded in that it was not included in a required list, and a notice or other information regarding the article was not provided as required--502(o).
DISPOSITION: The article was destroyed. (F.D.C. No. 67076; S. No. 95-739-449; S.J. No. 7

Cosmetics

PRODUCT: French bronze tablets, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-88-1936.
CHARGED 6-18-88: While held for sale after shipment in interstate commerce at FBNH Enterprises, Inc., d/b/a French Bronze Tablets, in Brooklyn, N.Y., the articles were adulterated in that they were not hair dyes, and they contained an unsafe color additive which had no regulations in effect for its use--601(e) and 721(a).
DISPOSITION: The articles were destroyed. (F.D.C. No. 65450; S. No. 88-457-959; S.J. No. 8

CRIMINAL ACTIONS

DEFENDANT: Mark Dalen, at Clarendon Hills, Ill. (N.D. Ill.); Criminal No. 96CR0691.
CHARGED 11-5-96: Count 1: The defendant introduced into interstate commerce a cosmetic that was adulterated in that it contained an unsafe additive--301(a) and 303(a)(1).
DISPOSITION: The defendant was sentenced to 36 months of probation and ordered to pay a $1,000 fine. (F.D.C. No. 66512; S.J. No. 9

DEFENDANTS: International Nutrition and Gene Oden, at Las Vegas, Nev. (D. Nev.); Criminal No. CR-5-95-27-PMP (LRL).
CHARGED: 2-3-95: Counts 1 to 4: The defendants introduced into interstate commerce unapproved new drugs--301(d) and 303(a)(1).
DISPOSITION: International Nutrition, which was found guilty on all counts, was sentenced to five years of probation and ordered to pay a $60,000 fine. Defendant Gene Oden, who pleaded guilty to counts one and two, was sentenced to five years of probation and ordered to pay a $5,000 fine. (F.D.C. No. 66861; S.J. No. 10

DEFENDANTS: Arthur and Juanita Mallard, at Mobile, Ala. (S.D. Ala.); Criminal No. 95-00193-AH.
CHARGED 2-15-96: Count 1: The defendants knowingly concealed property belonging to Arthur Mallard from the U.S. Bankruptcy Court and creditors--18 U.S.C. section 152.
Counts 2 to 3: Defendant Arthur Mallard, along with others, knowingly devised a scheme to defraud and obtain money from purchasers of Mallard's beauty products--18 U.S.C. section 1341.
Count 4: The defendants willfully attempted to evade the payment of federal income tax by placing funds and property in the names of nominees, by filing and causing the filing of false income tax returns, by filing and causing the filing of a false bankruptcy petition, by dealing in currency, and by other means--26 U.S.C. section 7201.
Count 5: Defendant Arthur Mallard knowingly subscribed to a false federal income tax return by not reporting additional income--26 U.S.C. section 7206(1).
Count 6: Defendant Arthur Mallard knowingly aided in the preparation of a fraudulent federal income tax return--26 U.S.C. section 7206(2).
Counts 7 to 13: Defendant Arthur Mallard, with the intent to defraud and mislead, knowingly devised a scheme to obtain money from purchasers of over-the-counter preparations which were also unapproved new drugs introduced into interstate commerce--505(a), 301(d), and 303(a)(2).
DISPOSITION: Defendant Arthur Mallard, who was found guilty on all counts, was sentenced to 11 years of imprisonment and three years of probation. He was also ordered to pay a $50,000 fine, a $650 special assessment, and $39.95 in restitution. Defendant Juanita Mallard, who was found guilty on counts 1 and 4, was sentenced to five years of imprisonment and three years of probation. She was ordered to pay a $10,000 fine and a $100 special assessment. (F.D.C. No. 66873; S.J. No. 11

DEFENDANT: Medicine Club International, Inc., at Ontario, Canada (D. Md.); Criminal No. AW-94-0373.
CHARGED 9-27-94: Count 1: The defendant, with the intent to defraud and mislead, introduced into interstate commerce an unapproved new drug--301(d) and 303(a)(2).
DISPOSITION: The defendant pleaded guilty and was sentenced to five years of probation and ordered to pay a $500,000 fine.
(F.D.C. No. 66581; S.J. No. 12

DEFENDANT: Warner-Lambert, at Morris Plains, N.J. (D. Md.); Criminal No. DKC-95-0463.
CHARGED 11-28-95: Count 1: The defendant, with the intent to defraud and mislead, failed to report information concerning the failures of distributed batches of drugs to meet stability testing specifications--301(e) and 303(a)(2).
DISPOSITION: The defendant pleaded guilty and was ordered to pay a $10 million fine. An individual was also indicted on five related counts. He was found not guilty at trial on three counts, and the remaining counts were dismissed. (F.D.C. No. 66419; S.J. No. 13

INJUNCTION ACTIONS

DEFENDANT: Charles A. Ellis d/b/a PIPA Laboratories, Inc., at Roslindale, Mass. (D. Mass.); Civil No. 93-10127 WD.
CHARGED 1-22-93: The defendant introduced adulterated drugs into interstate commerce--301(a) and 301(k). The drugs were adulterated in that the methods used in, and the facilities and controls used for, its manufacture, processing, packing, and storage were not in conformity with current good manufacturing requirements--501(a)(2)(B).
DISPOSITION: A consent decree of permanent injunction was filed. Subsequently, PIPA Laboratories, Inc., ceased operations. (Inj. No. 1284; S. No. 91-637-846; S.J. No. 14

DEFENDANTS: Laerdal Manufacturing Corp., and John Karpowicz, at Tualatin, Ore. (D. Ore.); Civil Action No. 93-1141-FR.
CHARGED 12-1-95: The defendants introduced adulterated and misbranded devices into interstate commerce--301(a) and 301(k). The devices were adulterated in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, and storage were not in conformity with current good manufacturing requirements--501(h). The devices were misbranded in that the defendants failed to file the required medical device reporting information--502(t)(2).
DISPOSITION: The district court enjoined the defendants for failing to furnish medical device reporting information. The corporate defendant filed an appeal, and the appellate court affirmed the district court's decision. Subsequently, the firm ceased operations. (Inj. No. 1326; S. No. 93-591-710/3; S.J. No. 15

DEFENDANTS: Royal Baltic Ltd., Vladamir Furleiter, and Alexander Kaganovsky, at Brooklyn, N.Y. (E.D. N.Y.); Civil Action No. CV-94-1178.
CHARGED 5-15-95: The defendants introduced into interstate commerce adulterated fish--301(a) and 301(k). The fish was adulterated in that it was prepared, packed and held under insanitary conditions whereby it might have been rendered injurious to health--402(a)(4).
DISPOSITION: A consent decree of permanent injunction was filed. (Inj. No. 1314; S. No. 92-647-646; S.J. No. 16

MISCELLANEOUS ACTIONS

ACTION: Bristol-Myers Squibb Co. v. Shalala and Kessler, at Washington, D.C. (D.D.C.); Civil Action No. 1:94CV01516.
CHARGED 7-13-94: The plaintiff, a pioneer drug manufacturer, challenged regulations authorizing approval of generic drugs for less than all indications approved for the pioneer product.
DISPOSITION: The district court dismissed the complaint for lack of constitutional standing. The plaintiff appealed, and the appellate court reversed the lower court's decision. The appellate court held that FDA may approve a generic version of a pioneer product when the pioneer enjoys exclusivity over one or more, but not all, indications. (Misc. No. 1040; S.J. No. 17

FDA Consumer magazine (July-August 1997)