Compliance Implications for Healthcare Companies Post-First Circuit Decision
The US Court of Appeals for the First Circuit’s landmark decision in United States v. Regeneron Pharmaceuticals will have some implications for healthcare compliance and defense strategies. In the case, the First Circuit adopted the more stringent “but-for” causation standard for claims under the False Claims Act (FCA) predicated on violations of […]
Complaint Against Uniform Company for Customs Duties Underpayment Highlights False Claims Act Risks for Tariff Compliance
As we discussed in this April 7 blog post, the US Department of Justice (DOJ) can pursue civil penalties for tariff evasion under the False Claims Act (FCA), including against companies that are aware of tariff evasion by their supply chain partners. The FCA risks are significant not only due […]
Tariffs Are Here – Be Aware of Criminal and Civil Enforcement Risks
On April 2, 2025, President Donald Trump, citing national security concerns, used authority granted under the International Emergency Economic Powers Act of 1977 to announce a sweeping new tariff regime, with a 10% baseline tariff for all countries, plus higher “reciprocal tariffs” for approximately 90 countries. These tariffs are “stackable” […]
SEC Now Requires Commission Approval for Subpoenas, but Says It Is Not ‘Walking Away’ From Enforcement
On March 10, 2025, the US Securities and Exchange Commission (SEC) adopted a final rule that will require a majority of the Commissioners to agree before the SEC formally opens an investigation. For the past 15 years, that power had been delegated to the SEC’s director of the Division of […]
Attorney General Issues Memorandum on Ending ‘Illegal’ DEI and DEIA Policies – Now What?
On February 5, 2025, US Attorney General Pam Bondi issued a memorandum titled Ending Illegal DEI and DEIA Discrimination and Preferences (memo or directive). The memo came down as part of Bondi’s[KZ1] 14 “first-day” directives – one of two directives that expressly address diversity, equity, inclusion and accessibility (DEI or […]
Expanded False Claims Law Puts Government Contractors on Notice
With both the False Claims Act and the Administrative False Claims Act now part of the federal arsenal, companies dealing with US government funds can expect to see increased scrutiny of alleged false claims by the Department of Justice and administrative agencies. Congress passed the Administrative False Claims Act in late December […]
Fourth Circuit Ruling Guts the Practice of Medicine Defense in FDA Cases
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson1 upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for a four-year, $4.7 million Medicare fraud scheme involving repeated use of surgical devices […]
Whistleblower Essentials for US Companies
Companies now face an increasingly complicated and evolving landscape of programs announced by prosecutors and regulators that give individuals a financial incentive to report corporate misconduct. In the last year, the US Department of Justice (DOJ) has established several such programs, which complement existing initiatives from the US Securities and […]
Federal Law Enforcement Recommends Encrypted and Ephemeral Messaging
In light of recent reports of cyberattacks on telecommunications companies, the FBI and the Cybersecurity and Infrastructure Security Agency (CISA) issued a series of reports and statements recommending secure communications, including using end-to-end encryption. At the same time, US regulators – including the Department of Justice (DOJ) and the Securities […]
SEC Announces FY2024 Enforcement Results, Including Record-Breaking Financial Remedies
The Securities and Exchange Commission (SEC) recently announced its enforcement results for fiscal year 2024, during which it obtained the highest amount of financial remedies in history at $8.2 billion, representing a 66% increase from FY2023. More than half of that amount is attributable to a $4.5 billion settlement following […]