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. MMS manufactures and markets disposable medical devices used in interventional and diagnostic procedures, including cardiology, radiology, oncology, critical care and endoscopy. The anti-kickback statute prohibits...

DOJ’s aggressive enforcement of the opioid industry is a striking example of the power of federal prosecutors when focused on an industry.  Once prioritized for enforcement, DOJ has quickly brought together prosecutors and law enforcement to target corporate actors and companies with the full force of criminal and civil statutes. In a significant case, DOJ announced the resolution of its criminal and civil investigations against...

We have a new poster-child for a defective corporate culture of wrongdoing.  Novartis has joined the exclusive club, along with Siemens, General Motors, Wells Fargo, and others in the misconduct Hall of Fame.  Within the space of two weeks, Novartis has settled FCPA violations for foreign bribery, and just recently, Novartis settled two separate cases in the United States for anti-kickback and False Claims Act...

The drug and medical device/testing industry is under significant pressure to develop new products to address the COVID-19 pandemic.  The federal government is increasing spending and support of drug and device companies in anticipation of developing a new vaccine, treatment products and testing.  As a result, pharmaceutical, medical device and diagnostic and laboratory tests will be subject to federal scrutiny and monitoring for proper use...

When Congress enacts massive financial relief legislation, one inevitable result is fraud, waste and abuse.  Going back to the financial crisis in 2008, DOJ had a trove of criminal fraud and civil fraud cases under the False Claims Act. With the passage of the CARES Act, you can count on DOJ ramping up criminal and civil fraud prosecutions, especially under the False Claims Act.  The...

Jessica Sanderson, Of Counsel at The Volkov Law Group rejoins us for her annual review of False Claims Act enforcement. Jessica can be reached at [email protected]. 2020 marks the 150th anniversary of the Department of Justice (“DOJ”), and it unwrapped a nice gift: On January 9, 2020, DOJ released its Fraud Statistics showing that it obtained more than $3 billion under the False Claims Act...

The Justice Department continues to aggressively pursue False Claims Act cases.  In 2019, DOJ recovered over $3 billion from healthcare, defense and financial companies.  The heath care sector — pharmaceutical, medical device, hospitals and healthcare providers — continues to be the primary focus of False Claims Act cases.  Qui tam relators initiate a significant percentage of all False Claims Act cases. In this episode, Michael Volkov...

The Justice Department has aggressively continued to pursue False Claims Act prosecutions against healthcare companies and physicians.  By the mid-point of 2019, DOJ had collected over $800 million against pharmaceutical and healthcare professionals.  In the last few months, DOJ has brought several significant prosecutions. In this Episode, Michael Volkov reviews recent healthcare fraud enforcement cases.

Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act.  While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and device firms, a relative risk analysis is likely to reveal that False Claims Act risks significantly outweigh FCPA risks (not to diminish FCPA risks, but relatively speaking). As an...

Companies that depend on federal funding (e.g. healthcare, government contractors and university researchers) face significant risks for False Claims Act prosecutions.  Relying on pro-government False Claims Act statutes, potential whistleblowers can earn enormous judgments by filing private actions under seal, and seeking federal government intervention in the matter, to prosecute False Claims Act violations.  In those cases where the federal government agrees to intervene, the...