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 the Office of the Chief Counsel, Food and Drug Administration.

SEIZURE ACTIONS

Food/Contamination, Spoilage, Insanitary Handling

PRODUCT: Shrimp, frozen, 1,493 cases, more or less, at Brownsville, Texas (S.D. Tex.); Civil Action No. B-95-017.
CHARGED 1-27-95: While held for sale after shipment in interstate commerce at Tex-Mex Cold Storage, Inc., in Brownsville, Texas, the article of food was adulterated in that it consisted in whole or in part of decomposed shrimp.
DISPOSITION: The article was destroyed. (F.D.C. No. 67036; S. No. 94-666-541; S.J. No. 1)

Drugs/Human Use

PRODUCT: Oxygen, at Sandusky, Ohio (N.D. Ohio); Civil Action No. 3:97CV7704.
CHARGED 10-28-97: While held for sale after shipment of one or more of its components in interstate commerce at Seeley Medical, Inc., in Sandusky, Ohio, the article of drug was adulterated in that the methods used in and the facilities and controls used for its manufacture, processing, packing, and holding did not conform to and were not operated and administered in conformity with current good manufacturing practice--501(a)(2)(B). The article of drug was misbranded in that its labeling failed to bear the statement "Caution: Federal law prohibits dispensing without prescription"--503(b)(4).
DISPOSITION: The article was reconditioned. FDA costs were paid and bond was released. (F.D.C. No. 67205; S. No. 97-765-575; S.J. No. 2)

PRODUCT: Oxygen, Liquid Medical, at Cumberland, Md. (D. Md.); Civil Action No. CCB 98-3410.
CHARGED 10-9-98: While held for sale after shipment of one or more of its components in interstate commerce at American Homepatient, Inc., in Cumberland, Md., the article of drug was adulterated in that the methods used in and the facilities and controls used for its manufacture, processing, packing, and holding were not in conformity with current good manufacturing practice--501(a)(2)(B).
DISPOSITION: The article of drug was reconditioned. Costs of supervision and court costs and fees were paid and bond was released. (F.D.C. No. 67250; S. No. 98-716-198; S.J. No. 3)

Medical Devices

PRODUCT: Excimer Laser System, at Orlando, Fla. (M.D. Fla.); Civil Action No. 97-982-CIV-ORL-19.
CHARGED 8-8-97: The article of device, in the possession of Dr. Albert Neumann at the Neumann Eye Institute, Inc., in Orlando, Fla., was adulterated because it was a Class III device under 21 U.S.C. Section 360c(f)(1), which was required to have in effect either an approved application for premarket approval (PMA) under 21 U.S.C. Section 360e, or an approved investigational device exemption (IDE) under 21 U.S.C. Section 360j(g), and no such PMA or IDE was in effect--501(f)(1)(B).
DISPOSITION: The article was destroyed. (F.D.C. No. 67192; S. No. 97-711-978; S.J. No. 4)

PRODUCT: One Excimer Laser System, at Atlanta, Ga. (N.D. Ga.); Civil Action No. 1:97-CV-1811-JOF.
CHARGED 6-24-97: The article of device, in the possession of Woodhams Eye Clinic, in Atlanta, Ga., was adulterated because it was a Class III device under 21 U.S.C. Section 360c(f)(1), and there was no approved application for premarket approval in effect pursuant to 21 U.S.C. Section 360e and no investigational device exemption was in effect pursuant to 21 U.S.C. Section 360j(g)--501(f)(1)(B).
DISPOSITION: The article was destroyed. (F.D.C. No. 67193; S. No. 96-720-783; S.J. No. 5)

Drugs/Veterinary Use

PRODUCT: Animal Drugs, at Redmond, Wash. (W.D. Wash.); Civil Action No. C94-1120C.
CHARGED 7-29-94: While held for sale after shipment of one or more of their components in interstate commerce at Argent Chemical Laboratories, Inc., in Redmond, Wash., the articles of drug 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 or, upon inspection, failed to conform to, and were not operated and administered in conformity with current good manufacturing practice--501(a)(2)(B).
DISPOSITION: The articles were destroyed. (F.D.C. No. 66900; S. No. 93-669-021; S.J. No. 6)

CRIMINAL ACTIONS

DEFENDANTS: Bruce George Paddock, Roscoe David Heim, Robert Pratt, and Paddock Laboratories, Inc., at Minneapolis, Minn. (D. Minn.); Criminal No. 3-94-65.
CHARGED 6-6-94: A 37-count indictment was returned against the three individuals and Paddock Laboratories, Inc., a pharmaceutical distribution company. The indictment alleged an illegal scheme between 1986 and 1990 to import and distribute minoxidil, a drug used to treat male baldness. The charges included conspiracy, customs violations, drug misbranding, and money laundering.
In addition to the criminal charges, the indictment sought the forfeiture of property and other assets that were involved in the money laundering operation, including over $900,000 in currency, all assets of the corporation, some real estate, and the four defendants' bank accounts. District Judge Paul Magnuson issued restraining orders preventing the defendants from disposing of such assets.
DISPOSITION: Bruce Paddock and Roscoe Heim were arrested on June 6, 1994. Bruce Paddock entered a plea agreement to a one-count felony Information on Oct. 20, 1994, and was sentenced to pay a $5,000 fine, serve one month of home detention with work release, perform 300 hours of community service, and serve three years' probation plus costs. Roscoe Heim also entered a plea agreement to a one-count misdemeanor Information on Oct. 20, 1994, and was subsequently sentenced to pay a $5,000 fine, perform 150 hours of community service, and serve three years' probation plus costs. All of the other counts against the pleading defendants and the corporation were dismissed as a part of the plea agreement. The third defendant was never found or arrested. (F.D.C. No. 66136; S. No. 90-529-435; S.J. No. 7)

MISCELLANEOUS ACTIONS

ACTION: Granutec, Inc. v. U.S. Department of Health and Human Services (D. N.C.); Civil Action No. 5:97-CV-485.
CHARGED 6-17-97: Plaintiff, Granutec, Inc. (Granutec), challenged the refusal of defendant Food and Drug Administration (FDA) to approve its application for a generic drug product, effective July 10, 1997. Granutec had followed all applicable FDA regulations and was entitled to a final approval effective on that date. Instead, FDA chose not to follow its own regulations and asserted that it could not approve Granutec's application until a later date.
DISPOSITION: Plaintiff sought and won July 13, 1997, a preliminary injunction ordering FDA to follow their regulations. FDA did not appeal, but intervenors did. As appellees, FDA defended their regulations. On April 3, 1998, the 4th Circuit Court of Appeals reversed the district court and held that FDA's regulations were inconsistent with statute and therefore invalid. (Misc. No. 1181; S.J. No. 8)

ACTION: Ashley Carolyn Mason, et al. v. Institutional Review Board for Human Research, Medical University of South Carolina, and FDA, at Charleston, S.C. (D. S.C.); Civil Action No. 2:89-2390-8.
CHARGED 9-29-89: The plaintiff, Ashley Mason, was an autistic patient undergoing treatment in Dr. Hugh Fudenberg's viral disease immunity transfer factor research, which was conducted at the Medical University of South Carolina (MUSC). Her treatment had been terminated on Aug. 31, 1989, when the Institutional Review Board (IRB) of the MUSC suspended the research program because of violations of IRB guidelines. The plaintiff brought this action to enjoin defendant IRB from suspending Dr. Fudenberg's treatment of patients.

In addition, as a result of violations of the investigational new drug regulations, the Food and Drug Administration (FDA) had placed a clinical hold on the research as to new patients on Aug. 7, 1989, and on Oct. 24, 1989, FDA prohibited further treatments of patients already in the program. Although FDA was not originally listed as a defendant, Judge Sol Blatt Jr. ordered that the agency be joined to the case after the court determined that any action ordered or taken by the IRB would be ineffectual given FDA's clinical hold.
DISPOSITION: On Nov. 30, 1989, Judge Blatt granted plaintiff's request for a preliminary injunction against the IRB and FDA, enjoining them from prohibiting Dr. Fudenberg's continued treatments of patients already under his care who wished to continue treatment. FDA filed an appeal asking that the preliminary injunction against it be dissolved and filed a motion to be dismissed from the case, which was granted on May 30, 1990. (Misc. No. 904; S.J. No. 9)

ACTION: Sokolow v. FDA, at Port Arthur, Texas (E.D. Tex.); Civil Action No. 1:97CV0252.
CHARGED 5-5-97: The plaintiff, the City Attorney of Port Arthur, Texas, submitted a Freedom of Information Act (FOIA) request in April 1997 seeking information on the status of premarket approval applications and investigational new drug applications regarding blood testing for sugar levels, Lou Gehrig's disease, Type I diabetes, and post-polio syndrome. The plaintiff alleged that FDA failed to process the request.
DISPOSITION: FDA provided Sokolow with all of the releasable documents that were responsive to the court order. The plaintiff then attempted to amend his complaint to seek additional information. FDA, therefore, moved for and was granted summary judgment on Feb. 19, 1998. The plaintiff appealed, but the Fifth Circuit upheld the district court's decision. (Misc. No. 1177; S.J. No. 10)

ACTION: Somerset Pharmaceuticals, Inc. v. Donna Shalala and Dr. David Kessler, at Wilmington, Del. (D. Del.); Civil Action No. 96-403.
CHARGED 8-5-96: The plaintiff, a pioneer drug manufacturer, sued the Food and Drug Administration (FDA) in an attempt to block approval of a generic competitor product.

On June 5, 1989, the FDA approved plaintiff's new drug application (NDA) for the drug selegiline hydrochloride, used in conjunction with other drugs for the treatment of patients with late-stage Parkinson's disease. Because it was the first drug manufacturer to obtain FDA approval for selegiline hydrochloride, plaintiff was granted the right of exclusive sales and marketing of its "Eldepryl" tablets (known as the "pioneer product") for seven years following FDA approval. Then on Aug. 24, 1995, after voluntarily taking the tablet off of the market, the plaintiff submitted yet another NDA to the FDA for a capsule formulation of "Eldepryl." Plaintiff's NDA for the "Eldepryl" capsules was approved by the FDA on May 15, 1996. Plaintiff's exclusivity period for its pioneer product expired on June 6, 1996, at which time generic drug manufacturers whose abbreviated new drug applications ("ANDAs") were approved by FDA could begin marketing and selling generic forms of selegiline hydrochloride. Plaintiff sued to enjoin the marketing of such generic products, arguing that FDA's approval of the generic products was arbitrary and capricious in that FDA did not require the generic manufacturers to conduct "active moiety" testing nor did the agency require them to market their drugs in capsule form.
DISPOSITION: The court denied plaintiff's request for a preliminary injunction. Plaintiff docketed an appeal, but it was then voluntarily dismissed. (Misc. No. 1159; S.J. No. 11)

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