U.S. v. Articles of Drug Consisting of Undetermined Quantities of Drugs Containing Caffeine, Ephedrine, Ephedrine Sulfate, Phenylpropanolamine HCL, Doxylamine Succinate, 88-2535

• Decision Date: 27 November 1989
• Docket Number: No. 88-2535,88-2535
• Citation: 890 F.2d 1004
• Parties: UNITED STATES of America, Appellee, v. ARTICLES OF DRUG CONSISTING OF UNDETERMINED QUANTITIES OF DRUGS CONTAINING CAFFEINE, EPHEDRINE, EPHEDRINE SULFATE, PHENYLPROPANOLAMINE HCL, DOXYLAMINE SUCCINATE, or any combination of those ingredients, or any other ingredients or combination of ingredients in tablet, capsule or other form, in any strength, color, shape or size, in any size container or in bulk, labeled or unlabeled, the appearance of which imitates, or allows it to be sold or marketed so as to imitate any other drug, including but not limited to drug products having the following physical characteristics; small pink, purple, or white heart shaped tablets; etc.; in the possession of, Midwest Pharmaceuticals, Inc., Omaha, Nebraska, Appellant. UNITED STATES of America, Appellee, v. MIDWEST PHARMACEUTICALS, INC. a/k/a B & S Distributors, Steven F. Sommers, Appellants, Robert S. Leibert.
• Court: U.S. Court of Appeals — Eighth Circuit

Page 1004

890 F.2d 1004

UNITED STATES of America, Appellee, v. ARTICLES OF DRUG CONSISTING OF UNDETERMINED QUANTITIES OF

DRUGS CONTAINING CAFFEINE, EPHEDRINE, EPHEDRINE SULFATE,

PHENYLPROPANOLAMINE HCL, DOXYLAMINE SUCCINATE, or any

combination of those ingredients, or any other ingredients

or combination of ingredients in tablet, capsule or other

form, in any strength, color, shape or size, in any size

container or in bulk, labeled or unlabeled, the appearance

of which imitates, or allows it to be sold or marketed so as

to imitate any other drug, including but not limited to drug

products having the following physical characteristics;

small pink, purple, or white heart shaped tablets; etc.;

in the possession of, Midwest Pharmaceuticals, Inc., Omaha,

Nebraska, Appellant.

UNITED STATES of America, Appellee, v. MIDWEST PHARMACEUTICALS, INC. a/k/a B & S Distributors, Steven F. Sommers, Appellants, Robert S. Leibert.

No. 88-2535.

United States Court of Appeals Eighth Circuit.

Submitted June 14, 1989.

Decided Nov. 27, 1989.

John M. O'Connor, New York City, for appellant.

Robert M. Spiller, Jr., Rockville, Md., for appellee.

Before JOHN R. GIBSON and WOLLMAN, Circuit Judges, and BROWN, ^* Senior Circuit Judge.

JOHN R. GIBSON, Circuit Judge.

Midwest Pharmaceuticals, Inc., appeals from a district court order permanently enjoining Midwest from selling, advertising, or marketing specified "look-alike" drug products. In an earlier appeal of this case, we remanded to the district court ¹ to revise its injunction to identify the specific drug products which Midwest is prohibited from selling or marketing, and the specific marketing techniques which Midwest may not employ. Midwest now argues that the injunction, as modified on remand, is overly broad because it is prevented from employing different marketing techniques, not found objectionable by the district court, to sell otherwise legal products. It argues that the injunction should be further revised to prohibit Midwest only from marketing the identified products or substantially similar products by the means found objectionable. We are satisfied that the injunction is carefully tailored to prohibit only those transactions which would either violate the law or allow Midwest to profit from earlier violations of the law. Accordingly, we affirm the judgment of the district court.

I.

This case involves an action brought by the Food and Drug Administration against Midwest arising out of its marketing and distribution of certain drug products which were alleged to be "misbranded" under federal law. The FDA objected to the marketing and distribution of these drugs, known alternatively as "look-alike drugs" or "imitation drugs," because their similarity to controlled substances made them susceptible to being "passed off" to the ultimate consumer as controlled substances. Federal law prohibits the misbranding of any drug in interstate commerce. 21 U.S.C. Sec. 331(b) (1982). A drug is considered misbranded under federal law if it is an imitation of another drug. 21 U.S.C. Sec. 352(i)(2) (1982). Under 21 U.S.C. Sec. 332(a) (1982), district courts are authorized to enjoin the misbranding of drugs in interstate commerce, and such drugs are subject to seizure under 21 U.S.C. Sec. 334 (1982).

In April 1984, law enforcement officials from the FDA seized drug products from Midwest on the ground that the drugs were imitations of other drugs by virtue of their physical appearance, physiological effects, and the manner in which they were advertised, marketed, distributed, and sold. The FDA sought to permanently enjoin Midwest from marketing these drug products. The district court found that the seized products were marketed as imitations of other drugs and were designed to be "passed off" as controlled substances. United States v. Articles of Drug, 633 F.Supp. 316, 324 (D.Neb.1986). Accordingly, the court found injunctive relief appropriate to restrain Midwest from further violations of the law, and enjoined Midwest from selling or marketing these imitation drugs. The injunction considered a drug to be an "imitation" of another drug if it met one of the following tests: (1) identical in shape, size, and color; (2) similar or virtually identical in gross appearance; (3) similar in effect to controlled substances; or (4) similar in concept.

Midwest appealed the injunction to this court, which held that the injunction failed to identify either the specific drug products which Midwest was prohibited from selling or marketing, or the marketing techniques which Midwest could not employ. United States v. Articles of Drug, 825 F.2d 1238, 1247 (8th Cir.1987). The district court was instructed upon remand to revise the injunction to clearly define the specific acts which were prohibited. Id. Referring to the injunction's four-part test for determining whether a drug was an "imitation," this court held that it was error to define "imitation" to include products which were "similar in concept" only. Id. We instructed the district court to review the products found to be "similar in concept" to determine whether they were "imitations" in light of the remaining three definitions. Id.

Upon remand, the district court made specific findings regarding the one drug which it had earlier found to be an "imitation" only because it was "similar in concept" to other drugs. It found that this drug was also identical in shape, size, color, and was similar in effect to an illegal drug and therefore affirmed its earlier conclusion that Midwest should be enjoined from marketing it.

The district court then specifically enumerated eight categories of drugs found to be imitations and thus subject to condemnation and injunction. The court emphasized that the drugs were misbranded on the basis of their resemblance to illegal drugs and the manner in which they were marketed, enabling them to be "passed off" as imitations of controlled substances. Accordingly, the order permanently enjoined Midwest from selling, advertising, or marketing the drugs in the enumerated categories.

In addition to the specific categories of drugs, the injunction challenged in this appeal also applied to: (1) drugs identical or substantially identical in appearance to those condemned as imitations; (2) drugs identical or substantially identical in shape, size, and color, or in gross appearance to controlled substances; and (3) drugs marketed by using allegations or implications that they are similar to controlled substances, using promotions that provide pictures or descriptions of the color of the drugs, and failing to provide the identity and quantity of the pharmacological ingredients. Midwest was further enjoined from distributing more than 5,000 dosage units to any individual buyer unless the buyer provided the name under which he did business, and certified both that he was regularly and lawfully engaged in the drug distribution business and that he understood that repackaging without relabeling would make the drug misbranded. ²

II.

The sole argument raised by Midwest in this appeal is that the injunction, as revised by the district court after the earlier appeal, is overly broad because it prohibits Midwest from marketing legal drugs through otherwise permissible marketing techniques. Midwest argues that the evidence before the district court established that many of the drug products sold by Midwest were not similar in gross appearance to any controlled substance and therefore could be sold without violating the law if it were permitted to use unobjectionable marketing techniques. Midwest contends that because the district court's finding of misbranding was based on the sale of these products in combination with Midwest's marketing techniques, it should be permitted to distribute these products using other marketing techniques. It points out that the injunction prohibits Midwest from selling...