Hope Medical Enterprises Inc. v. Fagron Compounding Services LLC, et al.

Analysis Group was retained on behalf of Fagron Compounding Services, a compound pharmaceutical developer and the defendant in an unfair competition litigation brought by Hope Pharmaceuticals, a competitor of Fagron. Hope claimed that Fagron marketed and sold drug compounds for the treatment of calciphylaxis that were neither clinically studied nor approved by the US Food and Drug Administration (FDA), allegedly in violation of the US Federal Food, Drug, and Cosmetic Act (FDCA) and unfair competition laws in five states.

An Analysis Group team led by Manager Erik Martino supported Vice President Nathan Trujillo, who submitted expert reports and testified at deposition on the assessment of damages.

A judge in the US District Court for the Central District of California found that Hope was not entitled to disgorgement of Fagron’s profits but granted Hope a permanent injunction barring Fagron from selling the at-issue drug compounds in most instances. The US Court of Appeals for the Ninth Circuit reversed the district court’s judgment, holding that enforcement actions of the FDCA must be brought by the FDA.