Teva Pharmaceuticals USA Inc. (Teva USA) and Teva Neuroscience Inc. (“Teva”) agreed to pay $450 million to resolve two matters that allege Teva violated the Anti-Kickback Statute (AKS) and the False Claims Act (FCA). Teva is the largest generic drug manufacturer in the United States. The settlement resolved two alleged kickback schemes: Medicare Cost-Sharing Scheme and Copay Assistance Foundations First, Teva has agreed to resolve...

“By making its services convenient for criminals, TD Bank became one,” Attorney General Merrick B. Garland. TD Bank joins the list of dysfunctional companies — add them to Wells Fargo, Wirecard, Volkswagen, General Motors, Goldman Sachs, and the hall of fame of financial scandals.  TD Bank became a criminal organization, its employees even stated so in email communications, and its leadership operated with a criminal...

The Justice Department has repeated on several occasions that it intends to aggressively prosecute corporations for sanctions and export controls violations.  The “New FCPA” is how the Justice Department characterizes its plan.  To execute the strategy, DOJ has assigned 25 new prosecutors.  This is the most important fact — unleashing 25 new prosecutors with the goal of bringing criminal cases against corporations and individuals will...

Boeing’s Plea Agreement includes two Separate Factual Statements — the January 7, 2021 DPA, which is discussed in a prior blog post, and a factual outline of Boeing’s breach of the original DPA, resulting in the current Plea Agreement.  The most recent Factual Statement covers Boeing’s DPA breach for failure to implement an effective ethics and compliance program that is “designed, implemented, and enforced to...

The Boeing 737 MAX case took another dramatic turn.  On July 24, 2024, the Department of Justice filed with the United States District Court for the Northern District of Texas a proposed plea agreement with Boeing.  The plea agreement, which has been filed under Federal Rule Criminal Procedure 11(c)(1)(C), requires the Court to approve and accept the deal.  The Court can reject the plea deal...

In this new era of aggressive sanctions enforcement, companies have to understand the red lines that define where criminal and civil enforcement risk increase.  In contrast to the history of FCPA enforcement, DOJ and OFAC have provided helpful guidance to alert companies where risks are likely to increase. Sanctions enforcement involves an off mix of civil and criminal line drawing.  On the civil side, OFAC...

In this new era of aggressive sanctions enforcement, companies have to understand the red lines that define where criminal and civil enforcement risk increase.  In contrast to the history of FCPA enforcement, DOJ and OFAC have provided helpful guidance to alert companies where risks are likely to increase. Sanctions enforcement involves an off mix of civil and criminal line drawing.  On the civil side, OFAC...

With the beginning of the era of the “New FCPA,” as coined by DOJ’s Deputy Attorney General Lisa Monaco, we now need to focus on third-party risk and sanctions enforcement.  The law, the practice and the risks are important and not just the same as FCPA legal requirements.  As we embark on a new criminal enforcement era surrounding sanctions violations, companies have to address this...

The U.S. Department of Justice’s Antitrust Division has intensified its scrutiny of healthcare platforms that integrate doctors with insurers, data, and other assets. Assistant Attorney General Jonathan Kanter described this trend as an “alarming” concentration of resources. In a significant move, the DOJ announced the establishment of the Task Force on Health Care Monopolies and Collusion. Kanter emphasized during a Washington Post Live event that...