## Facts

- The United States, acting through the FDA, seized approximately fifteen tons of drug products from Midwest Pharmaceuticals, Inc. in April 1984 and filed an FDCA condemnation action alleging the drugs were misbranded as “imitations” under 21 U.S.C. §§ 331(b) and 352(i)(2).
- Midwest Pharmaceuticals, Inc. was an Iowa corporation that also did business as B & S Distributors and U.S.A. Drugs.
- Midwest purchased lawful drug products in bulk, repackaged them, and sold them by mail order.
- Midwest placed advertisements in pornographic and biker magazines that suggested the products were illegal or controlled “street drugs,” rather than ordinary lawful drugs.
- The district court found that Midwest’s labeling and overall presentation were calculated to make the products look and seem like other drugs (including drugs associated with illicit use), and that this “imitation” character made the articles misbranded under the FDCA.
- Steven F. Sommers became president in January 1984, and Robert S. Liebert was a former president; both were involved in the litigation.
- The district court condemned the seized articles as misbranded and entered a permanent injunction under 21 U.S.C. § 332(a) barring Midwest from selling or marketing “any drug product similar in appearance and in effect to drugs seized in April 1984” by the FDA.
- Midwest appealed, challenging the statute’s constitutionality, the liability standard, the sufficiency of proof, the injunction’s breadth and specificity, and certain trial rulings (including dismissal of a counterclaim).

## Issues

1. Whether 21 U.S.C. § 352(i)(2) is unconstitutionally vague as applied because the term “imitation” fails to give fair notice of prohibited conduct.
2. Whether the district court applied an incorrect legal standard by treating Midwest as responsible for foreseeable “passing off” by downstream buyers or sellers.
3. Whether the government had to prove, and did prove, that a “substantial” amount of each seized product was actually passed off as another drug.
4. Whether the permanent injunction was overbroad or insufficiently specific under Federal Rule of Civil Procedure 65(d).
5. Whether the district court’s pretrial and trial rulings denied Midwest due process.
6. Whether the district court erred in dismissing Midwest’s counterclaim.

## Decision

- The Eighth Circuit affirmed the condemnation judgment insofar as it held the seized articles were misbranded “imitations” under 21 U.S.C. § 352(i)(2).
- The court rejected Midwest’s vagueness challenge, holding that “imitation,” read in the FDCA context and applied to Midwest’s conduct and presentation, gave adequate notice.
- The court affirmed the district court’s general approach to “imitation” and “passing off,” allowing liability where product appearance, labeling, and advertising were arranged so that deception in the marketplace was a natural and foreseeable result.
- The court rejected Midwest’s argument that the government had to prove a “substantial” amount of each drug was actually passed off; the misbranding finding could rest on the products’ overall presentation and intended market use.
- The court reversed in part and remanded with respect to injunctive relief, concluding the injunction’s language (barring sale of any drug “similar in appearance and in effect” to the seized drugs) was too broad and not stated with the precision Rule 65(d) requires.
- The court rejected Midwest’s due process arguments and affirmed dismissal of the counterclaim.

## Legal Principles

- A drug is misbranded under 21 U.S.C. § 352(i)(2) if it is an “imitation” of another drug; the inquiry looks to the product’s overall presentation in commerce, including labeling and advertising, and whether it is designed to be taken as something else.
- A vagueness challenge to § 352(i)(2) fails as applied where the defendant’s packaging and advertising make clear that the product is meant to mimic another drug in a way likely to mislead consumers.
- FDCA “imitation” misbranding does not require the government to prove a quantified, product-by-product showing that a “substantial” amount of each article was actually passed off; it is enough that the product’s presentation supports the finding that it is an imitation as sold and distributed.
- A seller may be held responsible under the FDCA where its design and advertising make downstream “passing off” a foreseeable and intended feature of the product’s market.
- Permanent injunctions issued under 21 U.S.C. § 332(a) must comply with Fed. R. Civ. P. 65(d): they must describe the restrained acts in reasonable detail and cannot rely on open-ended phrasing that leaves defendants uncertain about what conduct is barred.
- Injunctive relief must be tied to proven violations and framed to avoid sweeping in lawful conduct beyond the established misbranding theory.

## Conclusion

United States v. Articles of Drugs, et al., Midwest Pharmaceuticals, Inc. held that Midwest’s repackaged lawful drugs could be condemned as misbranded “imitations” under the FDCA based on their overall appearance and advertising suggesting illegal street-drug equivalents, and it upheld the core liability determination while sending the case back for a more specific, narrower injunction consistent with Rule 65(d).


United States v. Articles of Drugs, et al., Midwest Pharmaceuticals, Inc., 825 F.2d 1238 (1987)