Category: General

Avanos Medical Pays $22 Million to Settle Criminal Mislabeling Charges for Surgical Gowns

Avanos Medical, a global medical device company, agreed to pay $22 million to resolve criminal charges relating to its fraudulent misbranding of its MicroCool surgical gowns.  Avanos Medical falsely labeled the surgical gowns as providing the highest level of protection against fluid and virus penetration. As part of the settlement, Avanos Medical agreed to a three-year deferred prosecution agreement (DPA), in exchange for a payment...

DOJ’s Antitrust Division Charges Seris Security and Three Executives, and Announces Plea Agreement with G4S Secure Solutions in Bid-Rigging Conspiracy Involving Overseas Security Services

The Justice Department’s Antitrust Division returned a criminal indictment against Seris Security and three executives, Danny Vandormael, CEO of Seris, Peter Verpoort, Director for Security at Seris, and Jean Paul Van Avermaet, CEO of G4S Secure Solutions, for participating in the bid-rigging conspiracy for U.S. and NATO security contracts.  All of the defendants are Belgian nationals. In a separate action, G4S Secure Solutions entered into...

DOJ Antitrust’s Ongoing Criminal Investigation of Labor Market Collusion in Health Care Industry Nets DaVita and Former CEO

The health care industry is taking it on the chin these days.  As DOJ increases False Claims Act prosecutions, the primary targets are pharmaceutical, medical device and health care providers.  So let’s add to the list of risks and prosecutions coming down the line – DOJ’s Antitrust Division is targeting health care companies for labor market collusion agreements among competitors not to solicit or hire...

False Claims Investigations and Criminal Prosecutions: Recent Examples of Criminal Charges – a Lab Owner, A Physician and a Nurse Practitioner (Part V of V)

A False Claims Act case can easily turn into a criminal prosecution.  The Federal Bureau of Investigation often initiates criminal investigations as part of its commitment to reducing health care fraud.  Working closely with an Assistant U.S. Attorney, DOJ often prosecutes physicians, lab owners, and  associates in criminal cases stemming from fraudulent billing and unnecessary medical services. In a stark example, the owner and a...

Akron Ohio Health System Agrees to Pay Over $21 Million to Settle False Claims Act Violations for Improper Payments to Referring Physicians (Part IV of V)

Akron General Health Systems, a regional hospital system based in Akron, Ohio agreed to pay $21.25 million to resolve allegations under the False Claims Act that it maintained improper relationships with referring physicians, resulting in the submission of false claims to the Medicare program.  Akron General was acquired in late 2015 by the Cleveland Clinic Foundation.  The timing of the case and the investigation raise...

St. Jude Agrees to Pay $27 Million to Settle False Claims Act Charges for Selling Defective Heart Devices (Part III of V)

St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities.  St. Jude was acquired by Abbott Laboratories in early 2017. St. Jude failed to disclose serious health events caused by the early depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices which...

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...

Justice Department, HHS-OIG and Defense Investigators Bring Flurry of False Claims Act Cases (Part I of V)

The False Claims Act is a powerful enforcement tool.  The Justice Department with its partner agencies are ramping up enforcement efforts.  The Biden DOJ is preparing to implement an aggressive FCA program across healthcare, defense industries and other government contractors.  Combined with this initiative, DOJ recently implemented an antitrust enforcement task force relating to government procurement.  In this environment, companies have to address these risks...

New Sponsor: Clausematch

I am excited to welcome Clausematch, as a new sponsor of Corruption Crime and Compliance. The Volkov Law Team has been impressed with Clausematch’s unique compliance policy management product offerings. Clausematch provides effective and efficient policy management, regulatory change management and contract management. Clausematch brings digital transformation to governance, risk and compliance. POLICY MANAGEMENTClausematch brings digitalized workflows to policies and procedures, which can be linked,...

EU Whistleblower Directive: A Primer (Part IV of IV) – Protections, Prohibitions and Penalties

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...