Tagged: false claims act

Episode 180 — 2020 False Claims Act Review with Jessica Sanderson, Partner, The Volkov Law Group

Jessica Sanderson, Partner, The Volkov Law Group and Michael Volkov review significant developments in the civil False Claims Act (“FCA”) area from the past year. With mind-boggling federal spending in FY 2020 and the obvious potential for fraud, abuse, and misuse of the trillions of dollars of federal stimulus funds, we undoubtedly will see a considerable increase in FCA audits, investigations, enforcement actions, qui tam...

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...

The Long Path to a Whistleblower Recovery: Former CCO Vindicated by Merit Medical Systems False Claims Act Settlement (Part II of II)

Dr. Charles Wolf was the Chief Compliance Officer at Merit Medical Systems, Inc. (“MMS”), who ultimately became the federal whistleblower against MMS alleging violations of the Anti-Kickback Statute.  Dr. Wolf’s concerns were ultimately vindicated when the Justice Department intervened in support of his complaint.  MMS settled the case with DOJ and agreed to pay $18 million.  Dr. Wolf received $2.65 million from the settlement under...

Merit Medical Systems Settles False Claims Act Case for $18 Million (Part I of II)

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...

Indivior Solutions Pleads Guilty to False Statements and Agrees to Pay $600 Million to Resolve Criminal and Civil investigations for Marketing of Opioid Addiction Treatment Drug Suboxone

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...

Novartis Settles False Claims Act Cases and Pays $729 Million for Domestic Bribery Schemes

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...

Drug and Medical Device Fraud Risks Increase in Pandemic Era

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...

The CARES Act and DOJ Prosecution of Fraud

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...

False Claims Act 2019 Year in Review

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 jsanderson@volkovlaw.com. 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...

Episode 124 — False Claims Act 2019 Review

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...