Drug manufacturers participating in the Section 340B Drug Pricing Program now face a significant new litigation risk under the False Claims Act (“FCA”). In a recent decision, Adventist Health System v. AbbVie, the Ninth Circuit reversed a district court to hold that a covered entity can pursue an FCA qui tam action premised on 340B overcharging even though Section 340B itself provides no private right...
This is the sixth post in the Dorsey FCANow Blog’s FCA Basics Series covering the fundamentals of the False Claims Act (“FCA”), outlining FCA procedure and highlighting key facets of FCA practice. Today’s post discusses pre-litigation matters: government investigations and voluntary self-disclosure of violations. FCA Investigations There are a few different ways the government finds out about fraudulent activity. When a relator files a qui...
Deputy Assistant Attorney General Brenna Jenny reaffirmed DOJ’s commitment to targeting employment practices at organizations that receive federal funding with the False Claims Act during the Federal Bar Association’s annual Qui Tam Conference in Washington, D.C. In her prepared remarks, Jenny also identified fact patterns that represent the types of “antidiscrimination” FCA claims DOJ is pursuing. What was the state of play before Jenny’s remarks? In the...
The Department of Justice (DOJ) announced that False Claims Act (FCA) settlements and judgments surpassed $6.8 billion in FY 2025—the highest single-year total in FCA history.1 DOJ reported a record 1,297 qui tam filings and 401 new government investigations opened for the year. Healthcare fraud enforcement once again dominated the recoveries, accounting for more than $5.7 billion of the total. By the Numbers2 Total FCA recoveries:...
A recent decision by the U.S. District Court for the Northern District of California to reject a proposed $57 million settlement in a False Claims Act (FCA) litigation highlights the unique challenges and complexities that surround the resolution of FCA cases—challenges that set them apart from ordinary civil litigation. Background: The Tetra Tech Case The settlement arises from a case about the Hunters Point Naval...
The U.S. Department of Justice (DOJ) announced recently that settlements and judgments under the False Claims Act, 31 U.S.C. § 3729, et seq. (FCA) totaled approximately $2.7 billion in FY 2023 (October 1, 2022 – September 30, 2023). DOJ and whistleblowers were party to 543 settlements and judgments, a record high, and a fifty-percent increase from the 351 settlements and judgments obtained in FY 2022. ...
On June 1, 2023, a unanimous Supreme Court decision sought to clarify the meaning of “scienter” in the FCA context, which deals with the defendant’s knowledge (or lack thereof) that a claim for payment was false and intent to submit the false claim. See United States ex rel. Schutte v. SuperValu Inc., 143 S. Ct. 1391 (2023) (“SuperValu”). There, the Court ruled that “[f]or scienter,...
On July 26, 2022, the Eighth Circuit Court of Appeals issued an opinion interpreting the standard for the causal link the government must show to establish that a “false or fraudulent” claim under the False Claims Act (“FCA”) included “items or services resulting from a violation” of 42 U.S.C. § 1320a-7b(g), the federal anti-kickback statute. United States ex rel. Cairns v. D.S. Med. LLC, 2022...
The Department of Justice recently announced that it resolved two civil lawsuits filed under the qui tam, or whistleblower, provisions of the False Claims Act to the tune of nearly $4 million. The suits alleged that a suburban Chicago diagnostics company, SNAP Diagnostics, LLC, that provides home testing for sleep disorders was defrauding Medicare and four other federal health care programs through kickbacks and unnecessary...
The Department of Justice recently announced that a home-health services company has agreed to pay over $45,000 to resolve alleged False Claims Act (“FCA”) violations. Professional Family Care Services, Inc. (“PFCS”), a North Carolina corporation, faced allegations of fraudulent billing for work by an employee that was convicted of wire fraud and sentenced to prison for her role in the alleged scheme. For two years...
