Subject to Inquiry

Subject to Inquiry

THE LATEST ON GOVERNMENT INQUIRIES AND ENFORCEMENT ACTIONS

Government Investigations and White Collar Litigation Group

Mindy Sauter

Photo of Mindy Sauter Mindy boasts an extensive and distinguished career as a trial attorney, having honed her skills at the state level as a county prosecutor and at the federal level as an assistant U.S. attorney. With a wealth of experience spanning numerous high-stakes trials, her legal acumen and courtroom prowess have earned her widespread recognition. Mindy is a co-leader of the firm’s Healthcare Litigation and Enforcement Practice Group.

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Justice Department Issues First Declination Under NSD’s M&A Safe Harbor Policy to Private Equity Firm, Reinforcing Roadmap for Acquiring Firms

By Garen S. Marshall, Justin Givens, Mindy Sauter and Alex J. Brackett on Anti-Bribery and Corruption
On June 16, the U.S. Department of Justice’s (DOJ) National Security Division (NSD) and the U.S. Attorney’s Office for the Southern District of Texas (USAO-SDTX) announced their decision to decline prosecution of White Deer Management LLC (White Deer), a private equity firm that voluntarily disclosed export control and sanctions violations committed by its newly acquired… Continue Reading

Order Limiting Strict Liability Has Implications on FDCA Enforcement for Companies, Individuals

By Clint Narver, Eric Olshan, Mindy Sauter and James Hornsby on Enforcement and Prosecution Policy and Trends, Fraud, Deception and False Claims
On May 9, 2025, President Trump signed an Executive Order titled “Fighting Overcriminalization in Federal Regulations.” The Order seeks to reduce the regulatory burden on Americans and prevent individuals from being criminally penalized for unknowingly violating complex regulations.  In pursuit of these goals, the Order sets forth a policy “generally disfavor[ing]” strict liability crimes.  Agencies… Continue Reading

The Risks of Rushing In: A Closer Look at DOJ Criminal Division’s Updated Corporate Enforcement Policy in the Broader Enforcement Landscape

By Ryan Buchanan, Eric Olshan, Michael F. Easley, Jr., Garen S. Marshall, V. Kathleen Dougherty, Mindy Sauter, Roy Dixon III, Jordan LaPointe, Joie Johnston and Colin F. Brady on Fraud, Deception and False Claims
I. Introduction: More Clarity, But Not a Complete Roadmap On June 10, Matthew Galeotti, the Head of the U.S. Department of Justice’s (DOJ) Criminal Division, delivered remarks at an event hosted by the American Conference Institute,[1] in which he discussed recent updates to the division’s Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP).[2] The revisions mark… Continue Reading

Healthcare Fraud Enforcement in a Second Trump Administration: Trends, Priorities, and Implications

By Mindy Sauter, Clint Narver, Michael Elliott, Garen S. Marshall, Justin Givens, Michael J. Podberesky and Rhea Shahane on Fraud, Deception and False Claims
On May 12, 2025, the United States Department of Justice’s (“DOJ”) Criminal Division released a major policy memorandum outlining its enforcement priorities for the upcoming year. Unsurprisingly, the number one priority for the Division was investigating and prosecuting white-collar crimes related to waste, fraud, and abuse—and particularly healthcare fraud. This emphasis on prosecuting healthcare fraud… Continue Reading

FDA to Expand Unannounced Inspections of Foreign Facilities — Manufacturers, Research Firms Should Prepare

By Clint Narver, Mindy Sauter, Michael F. Easley, Jr. and Rhea Shahane on Compliance
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines and other medical products intended for American consumers and patients. The FDA stated that this new inspection strategy will ensure that foreign manufacturers receive the… Continue Reading

Key Takeaways From McGuireWoods’ Webinar on Enforcement Against PE Funds in Healthcare

By Brett Barnett, Mindy Sauter, Michael Elliott and Michael J. Podberesky on Compliance, Fraud, Deception and False Claims
McGuireWoods partners Brett Barnett, Mindy Sauter, Mike Elliott, and Michael Podberesky recently conducted a solution-oriented discussion of key enforcement and compliance developments that impact private equity (PE) funds in healthcare. They also highlighted relevant cases regarding the government’s increased interest in compliance diligence in the PE space. Read on to learn about the eight key… Continue Reading

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