Medical Device Legal News with Sam Bernstein: Episode 14
The Justice Insiders: FIFA Corruption Trial – Will the Feds Score Another Goal?
Rob DeConti on the Latest Guidance and Insights from the OIG at HHS
New York AG Letitia James, along with a bipartisan coalition of 48 other AGs and in coordination with the U.S. DOJ, announced a $202 million settlement in principle with Gilead Sciences, Inc. (“Gilead”), to resolve...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) jointly announced the next phase of the Administration’s “Whole-of-Government” approach to fighting health care...more
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...more
The Office of Massachusetts Attorney General (AG) Andrea Campbell announced the criminal indictment of several Massachusetts-based health care providers and their owners in connection with allegedly false claims they...more
As of February 18, 2025, the First Circuit Court of Appeals requires the government to prove “but-for” causation in Anti-Kickback Statute (AKS)-based False Claims Act (FCA) cases. The court reasoned in United States v....more
In United States v. Regeneron Pharmaceuticals Inc., the US Court of Appeals for the First Circuit held that when the government seeks to establish False Claims Act liability under the 2010 amendment to the Anti-Kickback...more
Second Circuit Partially Affirms Novartis’ Motion to Dismiss AKS Claims - Last week, the Second Circuit Court of Appeals affirmed the district court’s ruling that dismissed allegations from a whistleblower who claimed that...more
Owner, Operator of Texas Lab Charged for $79 Million Medical Testing Fraud Scheme - On November 20, Osman Syed, the owner and operator of a laboratory in Texas, was charged with three counts of health care fraud,...more
The U.S. Department of Justice (DOJ) announced in a Nov. 12, 2024, press release that an ophthalmology practice with offices located in West Central Florida (the Provider) entered into an approximately $1.3 million settlement...more
Judge Orders Government to Pay Relators a Cut of FCA Settlement - On November 4, a federal judge from the US District Court for the District of Massachusetts ordered the government to pay the relators’ share of a...more
On October 15, Maryland Attorney General Anthony G. Brown announced that his office reached a $27 million settlement with Precision Toxicology to resolve allegations that it submitted false claims to government health...more
US Supreme Court Declines to Consider AKS ‘Willfulness’ Question - On October 7, the US Supreme Court denied a petition in which a whistleblower asked the Court to decide whether a “willful” act under the federal...more
Florida Federal Judge Strikes Down FCA’s Qui Tam Provision as Unconstitutional - On September 30, US District Judge Kathryn Kimball Mizelle of the Middle District of Florida held in a historic decision that the federal...more
New York City Mayor Eric Adams Charged for Accepting Foreign Bribes - On September 26, New York City Mayor Eric Adams was charged with conspiracy to commit wire fraud, bribery, and two counts of soliciting donations from...more
Federal Court Permits Investors to Resume Kickback Suit Against Teva - After a two-year long stay, on August 30, Judge Karen S. Marston of the US District Court for the Eastern District of Pennsylvania ruled that investors...more
Texas Pharmaceutical Marketer Sentenced for $59 Million Medications Fraud Conspiracy - On July 12, Quintan Cockerell, a Texas pharmaceutical marketer, was sentenced to over two years in prison and ordered to pay more than...more
Chicago Laboratory Owner Charged with Defrauding Medicare in $60 Million COVID-19 Test Kit Scheme - The Chicago-based owner of two laboratories, Zoom Labs Inc. and Western Labs Co., has been charged with health care fraud...more
Florida Lab Owner Agrees to Pay Over $27 Million to Resolve Three Whistleblower Lawsuits - Daniel Hurt, the prior owner and operator of Fountain Health Services LLC, Verify Health, Landmark Diagnostics LLC, First Choice...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more
Hospital Executive and Three Physicians to Pay More Than $880,000 to Resolve Kickback Allegations - On Monday, December 4, 2023, a Lexington, Texas, hospital executive and three health care providers agreed to pay more...more
Medical Marketer Convicted of $55 Million Fraud Scheme - Late last week, a federal jury in the Northern District of Texas convicted Quintan Cockerell for his role in a $55 million fraud conspiracy involving TRICARE, a...more
DOJ’s First Criminal Securities Fraud Prosecution Related to COVID-19 Results in Eight-Year Sentence - Mark Schena, the former president of Arrayit Corporation, a Silicon Valley-based medical technology company, was...more
Below are noteworthy False Claims Act (FCA) decisions from the third quarter of 2023. The main issues in the cases are: Materiality. The Fourth Circuit held that a pharmacist’s efforts to falsify patient eligibility...more