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
A Florida jury recently found two laboratory co-owners of Innovative Genomics LLC (“IGX”) not guilty in connection with an allegedly fraudulent COVID-19 testing scheme. The Government alleged that from November 2019 through...more
Jury Acquitted Lab Owners in Nearly $40 Million COVID-19 Fraud Case - On March 27, a Florida jury acquitted two testing lab co-owners of conspiracy, health care fraud, and wire fraud charges. Innovative Genomics, LLC...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
Jury Clears SuperValu of Liability in Whistleblower FCA Prescription Pricing Case - A federal jury in Illinois recently found SuperValu not liable in a whistleblower lawsuit that accused the company of overcharging the...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
On February 18, 2025, the U.S. Court of Appeals for the 1st Circuit issued a highly anticipated ruling interpreting the relationship between the False Claims Act ("FCA") and the federal Anti-Kickback Statute ("AKS"), holding...more
President Trump Puts a “Pause” on FCPA Enforcement - On Monday, President Donald Trump signed an executive order (EO) pausing the enforcement of the Foreign Corrupt Practices Act (FCPA). According to the EO, the pause will...more
Massachusetts District Court Judge Applies Heightened Causation Standard in FCA Case - On January 6, a District Court of Massachusetts judge granted summary judgment for defendants on allegations of violating the...more
Seventh Circuit Considers When Legal Marketing Transforms Into Illegal Kickbacks - On December 4, the US Court of Appeals for the Seventh Circuit heard oral arguments regarding whether the January 2023 jury conviction of...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
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
Designed for busy in-house counsel, compliance professionals, and anti-corruption lawyers, this newsletter summarizes some of the most important international anti-corruption law and enforcement developments from the past...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
Each summer in recent years, the U.S. Department of Justice (DOJ) and associated fraud enforcement partners have indicted many health care defendants, in multiple cases across the country. This summer continued the tradition....more
DOJ Launches Corporate Whistleblower Awards Pilot Program - On August 1, the US Department of Justice (DOJ) announced the details of its new Corporate Whistleblower Awards Pilot Program. According to the DOJ, the...more
Welcome to the Summer 2024 issue of “FCA Enforcement & Compliance Digest,” our quarterly newsletter in which we compile essential updates on False Claims Act (FCA) enforcement trends, litigation, agency guidance, and...more
Halfway through 2024, the government’s False Claims Act (FCA) enforcement efforts show few signs of letting up. Last month alone, the Department of Justice (DOJ) announced at least five eight-figure FCA settlements,...more
On June 27, 2024, the Department of Justice (DOJ) announced its 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants for alleged participation in various health care...more
On 22 February 2024, the US Department of Justice (DOJ) published the statistics for federal civil fraud recoveries in Fiscal Year (FY) 2023. The DOJ announced that the “government and whistleblowers were party to 543...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
Last week, the Department of Justice (DOJ) announced a $12 million settlement with spinal device manufacturer, Innovasis Inc. (Innovasis), and senior executives Brent Felix and Garth Felix related to allegations that they...more
On April 29, 2024, the Department of Justice (DOJ) announced a $1.3 million settlement (Settlement) with a South Carolina clinical laboratory marketer and his marketing company, and three physicians and their medical...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
Introduction: On April 15, 2024, the Department of Justice’s (DOJ) Criminal Division announced a new Pilot Program on Voluntary Self-Disclosure for Individuals. Under this program, individuals who voluntarily disclose certain...more
Big Baby’s Big Foul: Former NBA Star Glen 'Big Baby' Davis Sentenced to 40 Months for Healthcare Fraud Scheme - On May 9, former Boston Celtics forward Glen “Big Baby” Davis was sentenced to 40 months in prison following...more