On June 11, 2025, Assistant Attorney General Brett A. Shumate issued an internal memorandum (the “Shumate memo”) to all Civil Division employees of the U.S. Department of Justice (“DOJ”), describing the Division’s enforcement...more
In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more
On February 1, 2022, the U.S. Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics for fiscal year (FY) 2021....more
In a move that reminds us that successful defendants can—and should—seek attorneys’ fees in the right case, a magistrate judge in the U.S. Court of Appeals for the Ninth Circuit awarded pharmaceutical company Aventis Pharma...more
On January 14, 2021, the U.S. Department of Justice (DOJ) reported its False Claims Act (FCA) statistics for fiscal year (FY) 2020. More than $2.2 billion was recovered from both settlements and judgments in 2020, the lowest...more
Through a January 9, 2020, press release, the Department of Justice (“DOJ”) reported more than $3 billion in total recoveries from settlements and judgments from fraud-related civil matters brought under the False Claims Act...more
1/13/2020
/ Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Comply ,
False Claims Act (FCA) ,
Fraud and Abuse ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
Medicare ,
Pharmaceutical Industry ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators ,
Stark Law ,
Statistical Analysis
On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more
6/7/2014
/ Certiorari ,
Dismissals ,
False Claims Act (FCA) ,
Healthcare Fraud ,
Medicare ,
Off-Label Use ,
Pharmaceutical Industry ,
Pleading Standards ,
Popular ,
Qui Tam ,
Rule 9(b) ,
SCOTUS ,
Split of Authority ,
Takeda Pharmaceuticals ,
Whistleblowers