On September 5, 2025, the U.S. Securities and Exchange Commission (SEC) brought enforcement actions against a public company and one of its executives for materially misleading statements. Although disclosure fraud cases are nothing new for the SEC, they have been a rarity thus far during the tenure of Chairman Paul S. Atkins. So, these cases
It has long been the law of the Eleventh Circuit that, under the False Claims Act (FCA) and Federal Rule of Civil Procedure 9(b), a relator must provide sufficient “indicia of reliability … to support the allegation of an actual false claim for payment being made to the government.” U.S. ex rel. Clausen v. Laboratory
On February 18, 2025, the First Circuit joined the Sixth and Eighth Circuits in adopting a “but for” causation standard in cases involving per se liability under the federal Anti-Kickback Statute (AKS) and the False Claims Act (FCA). In U.S. v. Regeneron Pharmaceuticals, the First Circuit held that for an AKS violation to automatically
On June 28, 2024, SCOTUS overturned the long-standing Chevron doctrine in its decision Loper Bright Enterprises v. Raimondo and Relentless v. Department of Commerce. The Court’s ruling will have a significant impact on industries regulated by federal agencies, which historically have issued “guidance” interpreting the statutes, rules, and regulations they administer. As one of
In a first-of-its-kind prosecution, federal prosecutors have charged two healthcare executives with unlawfully distributing controlled substances, such as Adderall, through a telehealth website. These charges demonstrate the Department of Justice’s intensified focus on enforcing federal controlled substances laws in the rapidly evolving digital health landscape.
The government bases the bulk of its controlled substances charges
On Thursday, May 9, 2024, the Department of Justice announced the formation of a new task force to guide antitrust enforcement in the healthcare industry. The body, named the Task Force on Health Care Monopolies and Collusion (HCMC), is housed within DOJ’s Antitrust Division and directed by longtime DOJ antitrust prosecutor Katrina Rouse.
Recent years have seen eye-popping judgments and settlements involving cases brought under the federal False Claims Act (FCA) and federal Anti-Kickback Statute (AKS). And healthcare companies have, unsurprisingly, focused their compliance efforts on these and other federal fraud-and-abuse statutes. But a recent decision out of the Second Circuit underlines the importance of incorporating state-level anti-fraud
On February 22, 2024, Assistant Attorney General Brian M. Boynton delivered remarks at the 2024 Federal Bar Association’s Qui Tam Conference. During those remarks, Boynton announced another record year for DOJ’s False Claims Act enforcement efforts. Specifically, Boynton announced, in 2023 alone, nearly $2.7 billion was recovered under the FCA and included the resolution of
As we near the Thanksgiving holiday, we wanted to take a moment to thank you — our readers. Eye on Enforcement has been a fun project for the Bradley’s Government Enforcement and Investigations team. But the ultimate goal of any blog is to be read, and we’re grateful to have so many devoted readers. And
The District of Massachusetts has joined the growing chorus of courts that have applied a heightened causation standard in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS).
U.S. District Judge F. Dennis Saylor recently ruled that the government must show a “but for” causal connection between an AKS violation and an allegedly