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...

The Directive’s robust prohibitions against retaliation for covered persons—including both attempts and threats— is meticulously outlined in Article 19. Among other things, Article 19 broadly prohibits retaliation in the following forms: Suspension, lay-off, dismissal or equivalent measures Demotion or withholding of promotion Transfer of duties, change of location of place of work, reduction in wages or change in working hours Withholding of training Negative performance...

Hope everyone had wonderful Fourth of July holiday. Alex Cotoia, Regulatory Manager, at the Volkov Law Group rejoins us for Parts III and IV of his series on the EU Whistleblower Directive. If you want to reach Alex, his email is [email protected]. Article 17 of the Directive explicitly incorporates the provisions of Regulation 2016/679 on the protection of natural persons with regard to the processing...

To all our clients, colleagues, friends and family, Happy 4th of July. Here’s to the great future ahead. Happy 4th!!

Alex Cotoia rejoins us for part II of his IV-part series on the EU Whistleblower Directive. Alex can be reached at [email protected]. Article 7 of the Directive instructs member states to encourage reporting through internal organizational channels first, where the risk of retaliation is remote, and the reported breach can be effectively addressed on an internal basis.[1] Private sector organizations with 50 or more workers...

Alex Cotoia, Regulatory Compliance Manager at the Volkov Law Group, joins us for an informative four-part series on the EU Whistleblower Directive. Alex can be reached at [email protected]. Directive 2019/1937 of the European Parliament and Council dated 23 October 2019 on the “protection of persons who report breaches of Union law” (the “Directive”)[1] is set to enter into legal force on 17 December 2021—the deadline...

We all know and hear about third-party risks – over and over again. Despite this recurring theme, organizations continue to pay the price for failing to address third-party issues.  It does not take a rocket scientist to address third-party risks.  All too often, corporations flirt with a third party because of the lure of a lucrative deal, an elusive contract, or a winning bid. When...

FCPA settlement actions often underscore specific compliance risks for legal and compliance professionals. If there ever was a case where third-party risks were bungled, and even intentionally embraced, the Foster Wheeler case provides  an important reminder for any organization focusing on third-party risk management.  The Foster Wheeler FCPA resolution could not be timed any better – with the expected increase in FCPA enforcement activity, DOJ...