## Facts

- Sandoz Pharmaceuticals Corporation and Richardson-Vicks, Inc. competed in the over-the-counter cough syrup market.
- Vicks marketed “Vicks Pediatric Formula 44” as a non-narcotic pediatric cough remedy and advertised that it “starts to work the instant it is swallowed,” attributing immediate relief to demulcents that soothed the throat on contact.
- Vicks also made comparative/superiority claims suggesting Pediatric 44 outperformed competing products, including Sandoz’s.
- The formula included demulcents that Vicks treated as the basis for the “instant” claim, but those ingredients were not listed as “active ingredients” on the label and were not FDA-approved as cough actives.
- Sandoz sued under Lanham Act § 43(a), seeking a preliminary injunction to stop the advertising as false and deceptive.
- Sandoz argued that (a) Pediatric 44’s effectiveness claims were inadequately substantiated under FDA-related standards and (b) the alleged FDA labeling/approval deficiencies rendered the advertising per se false.
- After an evidentiary hearing, the district court denied preliminary injunctive relief, finding Sandoz failed to prove falsity or deception and failed to show irreparable injury.

## Issues

1. In a Lanham Act § 43(a) false-advertising case, can a plaintiff prevail by showing the defendant’s drug-efficacy claims lack “adequate substantiation” under FDA-related guidelines, without proving literal falsity or consumer deception?
2. Does alleged noncompliance with FDA labeling/approval requirements (including omission of asserted actives from “active ingredients”) constitute a per se Lanham Act violation?
3. Did the district court abuse its discretion or commit legal error in denying a preliminary injunction for lack of proof of falsity/deception and irreparable harm?

## Decision

- The Third Circuit affirmed the order denying a preliminary injunction.
- The court rejected the theory that insufficient FDA-style substantiation or FDA noncompliance, by itself, makes advertising “false” under Lanham Act § 43(a).
- The court upheld the finding that Sandoz failed to carry its burden to show Vicks’s “instant” and superiority claims were literally false or misleading to consumers.
- The court found no clear error in the district court’s factual findings and no abuse of discretion or legal error in denying preliminary relief, including on irreparable harm.

## Legal Principles

- A Lanham Act § 43(a) plaintiff challenging advertising claims of product effectiveness must prove the claims are literally false or misleading to consumers; showing the claims are unproven or inadequately substantiated is insufficient.
- FDA/FDCA regulatory standards and alleged regulatory noncompliance do not automatically establish falsity and do not convert the Lanham Act into a private enforcement mechanism for FDA rules.
- Evidence of regulatory status or labeling practices may be relevant to whether a representation is false or misleading, but it is not dispositive absent proof of falsity or consumer deception.
- Preliminary injunctive relief in false-advertising cases requires proof meeting the plaintiff’s burden on likelihood of success (including falsity/deception) and irreparable harm; appellate review is deferential to the district court’s factual findings and equitable judgment.

## Conclusion

The court held that competitor suits under Lanham Act § 43(a) require proof that advertising is false or misleading to consumers, and that alleged lack of FDA-style substantiation or FDA labeling/approval deficiencies, standing alone, does not establish per se false advertising; on the record presented, Sandoz failed to justify preliminary injunctive relief.


Sandoz Pharms. Corp. v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990)