The enforcement landscape entering 2026 points to sustained False Claims Act activity across traditional health care fraud, AI-enabled misconduct, civil rights–based claims, customs and tariff fraud, and expanding theories of investor liability.
For the past several years, the use of contract sales forces by pharmaceutical and device manufacturers and other suppliers has been under a heightened enforcement spotlight.
In recent months, three federal courts have refused to enforce expansive US Department of Justice (DOJ) administrative subpoenas issued to providers of gender-affirming care, concluding the subpoenas were issued for an improper purpose or exceeded the government’s statutory authority. These rulings are significant.
On December 12, the Eleventh Circuit heard the much-anticipated oral arguments in United States ex rel. Zafirov v. Florida Medical Associates LLC concerning the constitutionality of the False Claims Act’s (FCA) qui tam provisions.
Judge Kathryn Kimball Mizelle’s ground-breaking decision in Zafirov v. Florida Medical Associates LLC and Justice Clarence Thomas’ solo dissent in US ex rel. Polansky v. Executive Health Resources Inc. have revived what many had viewed as a settled constitutional question.
Welcome to the November 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.
Last week’s jury convictions of Safe Chain Solutions’ co-owners in United States v. Brosius, No. 1:24-cr-20255 (S.D. Fla.) coupled with US Food and Drug Administration (FDA) Drug Supply Chain Security Act (DSCSA) enforcement make one conclusion unavoidable: The DSCSA is both a regulatory mandate and a criminal risk boundary.
Investigations Partners Hillary Stemple and Nadia Patel will host a CLE webinar on how health care organizations’ compliance officers and general counsel can bolster compliance mechanisms in light of the re-launch of the Department of Justice and Department of Health and Human Services’ False Claims Act (FCA) Working Group.
Welcome to the September 2025 issue of “As the (Customs and Trade) World Turns,” our monthly newsletter where we compile essential updates from the customs and trade world over the past month. We bring you the most recent and significant insights in an accessible format, concluding with our main takeaways — aka “And the Fox Says…” — on what you need to know.