On July 25, the U.S. Court of Appeals for the Second Circuit affirmed the U.S. District Court for the Southern District of New York (SDNY) decision granting summary judgment in favor of the Department of Health Human Services (HHS) in Pfizer’s landmark challenge against the Office of Inspector General’s (OIG) interpretation of the federal Anti-Kickback Statute (AKS).

Continue Reading Second Circuit Agrees that the Anti-Kickback Statute Does Not Contain a “Corruption” Element

On January 25, in a 2-1 decision in U.S. ex rel. Sheldon v. Allergan Sales, LLC, 2022 WL 211172, the Fourth Circuit became the most recent federal appellate court to hold that the objective scienter standard in the Supreme Court’s Safeco decision applies to the False Claims Act (FCA). Under the Fourth Circuit’s decision, the FCA’s scienter element cannot be met if the defendant’s interpretation of applicable statutory or regulatory requirements was objectively reasonable and no authoritative guidance from a circuit court or government agency warned the defendant away from its interpretation.

Continue Reading Fourth Circuit Adopts Safeco’s Objective Reasonableness Standard for False Claims Act

The FCA continues to be the federal government’s primary civil enforcement tool for investigating allegations that healthcare providers or government contractors defrauded the federal government. In the coming weeks, we will continue to take a closer look at recent legal developments involving the FCA.  This week, we examine the requirement that a relator plead and prove that a defendant acted with the requisite level of knowledge to establish an FCA claim and evaluate how courts have evaluated this issue in recent cases.

To prevail in FCA cases, relators or the government must prove that the defendant acted with the requisite level of knowledge in connection with the FCA allegations at issue. In a number of cases, defendants made considerable headway in convincing courts to scrutinize allegations of knowledge closely, particularly in instances where defendants argued that the underlying conduct at issue was governed by ambiguous statutes or regulations.

Continue Reading Deeper Dive: Meeting the FCA’s Intent Requirement