By: Daniela Melendez, Associate at The Volkov Law Group and Alex Cotoia, Regulatory Compliance Manager at The Volkov Law Group Since its enactment in 2019, the European Union (“EU”) Directive on Whistleblowing 2019/1931 (“EU Directive”) has required all 27 EU Member States to incorporate certain requirements pertaining to the protection of whistleblowers into their own bodies of national law. The EU Directive alloted 2 years...

In a unanimous ruling, the Supreme Court reaffirmed the whistleblower protections of the Sarbanes-Oxley Act in the case, Murray v. UBS Securities, LLC et al. (February 8, 2024).  The Supreme Court’s decision reaffirms an ongoing trend — to protect and encourage whistleblower reporting as a means to enforce proper corporate governance.  The European Union’s Whistleblower Directive and new United States whistleblower incentive programs continue to...

The Biden Administration warned the healthcare industry that it would aggressively prosecute fraud cases.  The Justice Department is executing on that promise and doing so with great success.  Week after week, we read about False Claims Act settlement with multi-million dollar penalties.  We barely hear much about healthcare compliance innovation and strategies — the industry is clearly treading water when it comes to proactive compliance...

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...

Alex Cotoia, Regulatory Manager and Compliance Consultant at the Volkov Law Group, re-joins us for a posting on whistleblower protections. Alex can be reached at [email protected]. When Congress overrode former President Donald J. Trump’s veto of the 2021 National Defense Authorization Act (“NDAA”) in January of this year, it simultaneously enacted the Anti-Money Laundering Act of 2020 (“AMLA”) into law. AMLA significantly expands upon the...

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...

Global companies face a number of challenges and a myriad of regulatory obligations. In December 2019, the EU adopted a directive  to promote and protect persons who report violations of law.  The EU Whistleblower Directive was adopted in response to a series of scandals that were reported by whistleblowers, including the Panama Papers and the Cambridge Analytica scandal.  An EU-sponsored study in 2017 reported that...

One of several difficult compliance questions facing companies revolves around reporting of employee concerns. If the number of complaints coming in on a company hotline goes down over time, is corporate misconduct going down or are employees losing trust in the company’s speak up system? These are two diametrically opposite conclusions. Compliance officers have to be realistic and objective when analyzing this question. Misconduct rates...

There are many important predictors of corporate culture. Everyone laments the difficult in measuring a company’s culture. There are a few issues, however, that may be inconvertible as a predictor of a corporate culture. How does a company react to a whistleblower? I am sure everyone is saying to themselves – well, we do not have that problem,  we are committed to fair treatment of...

Happiness is when what you think, what you say, and what you do are in harmony – Mahatma Gandhi Happiness is an elusive concept – for some. For others who may be more enlightened or lived for years, happiness is a feeling that can be attained by commitment, determination and awareness.  My keys to happiness are love, gratitude and empathy. Some people are “content” being...