SCOTT ROSE, et al, Plaintiffs-Appellees,
STEPHENS INSTITUTE, DBA Academy of Art University, Defendant-Appellant.
ON APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE NORTHERN DISTRICT OF CALIFORNIA, OAKLAND
IN CASE NO. 4:09-CV-05966-PJH, HONORABLE PHYLLIS J. HAMILTON
BRIEF FOR AMICUS CURIAE NATIONAL NURSES UNITED (“NNU”) – CALIFORNIA NURSES ASSOCIATION, ET AL. IN SUPPORT OF PLAINTIFFS-APPELLEES
Amici curiae are healthcare-focused unions and policy advocates, practicing physicians, academics, and researchers: some have served as medical consultants to pharmaceutical manufacturers, including to their marketing teams. 1 Amici have seen firsthand – both in a clinical setting and in consulting capacities – the harm that can occur when manufacturers violate the Food, Drug & Cosmetics Act (“FDCA”) and False Claims Act (“FCA”) by promoting their drugs for off-label uses that have not been approved by the Food & Drug Administration and that have often been unsafe or ineffective.
Amici have a strong interest in the questions presented in this case, which are fundamental to the scope of liability under the FCA. Amici believe the FCA has fostered evidence-based medicine, prevented patient harm, and facilitated recovery of billions of dollars for the government. Amici are united by a goal to preserve the FCA as an effective tool to combat improper off-label promotion and other fraudulent conduct that causes the government to pay money not lawfully owed.
For decades, violations of the FDCA and other regulations have served as predicates for liability under the FCA in cases where the violations are material and the defendant acts with scienter to divest the government of money it does not lawfully owe. Last year, the United States Supreme Court rejected invitations to overturn Congressional intent and limit FCA liability to situations in which a defendant makes express false statements during the process of submitting claims to the government. See Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). Appellant and amici supporting Appellant seek to relitigate Escobar and ask this Court to adopt interpretations that vitiate its holdings, holdings of other Supreme Court decisions, and this Court’s existing precedent.
Amici agree that Appellees’ interpretations are consistent with the mandates of Escobar and the Supreme Court’s prior FCA decisions as well as this Court’s existing precedent. Amici submit this brief because Appellant’s contrary interpretations and the interpretations of amici such as the United States Chamber of Commerce have wide-ranging implications beyond the instant case and, if adopted, would gut the effectiveness of the False Claims Act as a tool to combat fraud.
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