On January 7, 2025, in the last weeks of the Biden Administration and before President Trump returned to the White House, the Food and Drug Administration (FDA) issued draft guidance, entitled “Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products.” This guidance provides recommendations on the use
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Stringent Requirements for Pleading Fraud Under Rule 9(b).
Dr. John Pepe and Dr. Richard Sherman (“Relators”), acting as whistleblowers, brought a qui tam action against Fresenius Medical Care Holdings, Fresenius Vascular Care, Inc., and Dr. Gregg Miller (“Defendants”). Relators’ complaint alleged that the Defendants engaged in fraudulent billing practices under the False Claims Act (“FCA”) and analogous state laws. Last week, the United…
General Allegations Without Representative Examples Are Insufficient to Survive a Motion to Dismiss
The United States District Court for the Northern District of Indiana recently dismissed a case involving allegations of fraudulent Medicaid claims and self-referrals. The case, United States of America and State of Indiana ex rel. Bradley A. Stephens v. Nuclear Cardiology Associates (“NCA”), serves as a critical reminder of the stringent requirements for pleading fraud…
The Anatomy of a Failed Qui Tam Case: Lessons from U.S v. Radiation Therapy Services
In the world of False Claims Act (“FCA”) litigation, the recent case United States ex rel. Robert C. O’Laughlin, M.D. v. Radiation Therapy Services, P.S.C., et al. serves as an important reminder of the need for concrete evidence when asserting qui tam FCA claims.…
Future Promises of Compliance with Federal Laws Cannot Form the Basis of a False Claims Act Violation
The United States District Court for the Eastern District of Michigan recently dismissed a False Claims Act (“FCA”) lawsuit brought against the City of Detroit. The core issue in United States ex rel. Lynn v. City of Detroit revolved around Detroit’s annual certifications and assurances to comply with federal laws and regulations as a condition…
How much (information) is too much? Caselaw shines a light on avoiding privilege waiver.
United States of America v. Sutter Health is exemplary of the delicate balance courts must strike when dealing with attorney-client privilege. Here, the United States District Court for the Northern District of California denied the relator’s motion for determination as to waiver of privilege, but granted alternative relief.
This case involves alleged violations of…
Significant Implications for FCA Defendants: Second Circuit Clarifies “Willfulness” in McKesson Decision
In a pivotal ruling that may reshape the landscape of False Claims Act (“FCA”) litigation, the United States Court of Appeals for the Second Circuit adopted a nuanced interpretation of “willfulness” under the federal Anti-Kickback Statute (“AKS”).…
Monumental Reduction in FCA Damages Based on Excessive Fines Clause
In a recent landmark decision, the United States District Court for the District of Minnesota dramatically reduced the damages and penalties awarded in a major False Claims Act (“FCA”) case. United States of America ex rel. Kipp Fesenmaier v. The Cameron-Ehlen Group, Inc., et al., Case No. 13-cv-3003 (D. Minn., Feb. 8 2024) (Dkt. 1086).…
ONC Releases Final Rule on Information Blocking and Health IT Certification Program Updates, Including Requirements Related to AI
On December 13, 2023, the U.S. Department of Health and Human Services’ (HHS) Office of the National Coordinator for Health Information Technology (ONC) released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule.…