Tagged: medical device

Alere Agrees to Pay $38.75 Million to Settle False Claims Act Violations (Part II of V)

Alere, Inc. and its San Diego subsidiary, agreed to pay $38.75 million to resolve False Claims Act charges for billing the Medicare program for defective rapid point-of-care testing devices. Alere sold diagnostic devices knowing that the devices had a materially defective algorithm.  During the period 2008 to 2016, Alere sold defective INRatio-blood coagulation monitors used by Medicare patients taking anticoagulant drugs (e.g., warfarin).  Blood coagulation...

Blue Umbrella Webinar: Anti-Corruption Risks and Compliance Trends in the Pharmaceutical, Medical Device and Life Science Industries

Tuesday, May 11, 2021 1 PM EST Sign-Up HERE Pharmaceutical, medical device and life science companies continue to face escalating anti-corruption risks in the global marketplace.  Companies in these industries face a complex global maze of foreign government laws and regulations that create significant risks for global companies in these sectors. The U.S. Department of Justice, the Securities and Exchange Commission, and foreign law enforcement...

Episode 168 — Review of Merit Medical False Claims Act Settlement

Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to induce increased use of MMS products. Dr. Charles J. Wolf, Merit’s former chief compliance officer, filed a whistleblower complaint against the firm in April 2016 following his resignation, in which he...

Doing Business in China Should Be “Scary”

Lauren Connell, Managing Associate at The Volkov Law Group, joins us again for another posting on corruption risks in China.  Her profile is here and she can be reached at lconnell@volkovlaw.com. A little fear is healthy. It will keep you vigilant and aware. At this point if corporate compliance departments are not a little fearful of doing business in China then their managers and employees...

Anti-Kickback Enforcement – Steady and Aggressive

When commentators criticize the FCPA for its broad coverage of international business operations, these same commentators would have real trouble with the US Anti-Kickback statute. Talk about broad coverage and then complicate it with specific exemptions that are challenging to interpret and apply. When it comes to fraud enforcement in the healthcare industry, the Justice Department wields a mighty stick – the False Claims Act....