Amicus in Rose, et al, v Stephens Institute

SCOTT ROSE, et al, Plaintiffs-Appellees,
v
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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Amincus in Rose v Stephens Institute.

GBB files amicus on behalf of law professors in FCA case before Supreme Court

Congress intended the False Claims Act to apply broadly and reach all fraudulent attempts to cause the United States Government to pay out money. In Universal Health Services, Inc. v. United States ex rel. Escobar, a key case pending before the United States Supreme Court, the Petitioner has urged a counter-textual interpretation that would vitiate the False Claims Act and compromise Congress’ intent.  On behalf of a distinguished group of law professors, Guttman, Buschner & Brooks PLLC has filed an amicus brief in the matter.

The amicus brief proposes a comprehensive model, the application of which will ensure the Act continues to effectuate Congress’ intent.  As the brief explains, the starting point for determining whether conduct is fraudulent and should be captured by the Act begins by looking to principles of common law fraud. However, Congress expanded upon the liability available under the False Claims Act, specifically by eliminating traditional reliance and scienter requirements of common law. Application of the Act’s statutory provisions expanding liability, coupled with use of limiting principles of materiality – routinely applied to other fraud statutes to ensure minor violations are not cognizable – balances concerns of the Act’s over-expansion with its stated purpose to broadly reach all fraudulent or deceitful acts that cause the Government to pay out money.

The full amicus brief is available here: Universal Health Services Inc v US and Massachusetts, ex rel Escobar and Correa – Brief of Law Professors as Amici.