## Facts

- Solvay marketed Estratest, a hormone replacement drug, for decades.
- Breckenridge introduced Menogen in 1997 and marketed it as a generic equivalent to Estratest.
- Solvay asserted Menogen copied Estratest’s trade dress and that Breckenridge falsely advertised generic equivalence in violation of the Lanham Act and Florida unfair-competition law.
- Breckenridge filed a declaratory judgment action seeking a ruling of no trade dress infringement and no Lanham Act false advertising; Solvay counterclaimed on those theories and related state-law claims.
- The district court granted summary judgment for Breckenridge, finding no likelihood of confusion and applying a reduced standard for assessing equivalence because it believed both products were permissibly marketed without FDA approval.
- On appeal, the United States filed an amicus brief asserting that neither product was lawfully marketed under the FDCA/DESI framework, prompting the appellate court to request supplemental briefing on whether Lanham Act relief is available for drugs sold in violation of FDA requirements.
- Before supplemental briefing was completed, Solvay moved to dismiss its appeal with prejudice; Breckenridge did not oppose dismissal but sought appellate fees and costs as sanctions for a frivolous appeal.

## Issues

1. Whether to grant the appellant’s motion to dismiss the appeal with prejudice after the appeal raised questions about the drugs’ regulatory status.
2. Whether appellate sanctions (fees and costs) were warranted under Fed. R. App. P. 38 based on alleged frivolousness.
3. Whether counsel’s representations regarding FDA regulatory status warranted referral for disciplinary review.

## Decision

- The court granted Solvay’s motion and dismissed the appeal with prejudice.
- The court did not reach the merits of the Lanham Act trade dress or false advertising claims, including the requested supplemental issue concerning FDCA illegality and Lanham Act relief.
- The court raised, on its own initiative, whether the conduct of counsel for both parties warranted referral to the court’s disciplinary committee.
- The court did not award Rule 38 attorneys’ fees and costs in the disposition described.

## Legal Principles

- An appellate court may dismiss an appeal with prejudice on the appellant’s motion, ending merits review.
- Where resolution of Lanham Act claims would depend on disputed FDA/FDCA compliance, courts may treat the matter as presenting a threshold regulatory concern and may decline to reach the merits if the case is terminated procedurally.
- Courts may initiate review of attorney conduct and potential disciplinary referral when submissions suggest incomplete or misleading representations, including about regulatory compliance.
- Appellate sanctions for frivolous appeals under Fed. R. App. P. 38 are discretionary and require an affirmative award by the court.

## Conclusion

The appeal was dismissed with prejudice at the appellant’s request, leaving the district court’s summary judgment for Breckenridge unreviewed and the FDCA–Lanham Act interaction unresolved, while the court signaled possible disciplinary scrutiny due to concerns about counsel’s representations regarding the drugs’ regulatory status.


Florida Breckenridge, Inc. v. Solvay Pharmaceuticals, Inc., 174 F.3d 1227 (11th Cir. 1999)