Webcast: 2017 Mid-Year Update: The False Claims Act and Drug and Device Manufacturers

August 2, 2017

​The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated. The U.S. Department of Justice has made clear that vigorous FCA enforcement is here to stay,  with newly filed cases remaining at historical peak levels and the DOJ  on pace to recover more than $3 billion from FCA cases for the seventh straight year.  More than ever, any company that deals in government funds—including companies in the education, health care and life sciences, government contracting and financial services sectors—needs to stay abreast of how the government and private whistleblowers alike are wielding this tool, and how they can prepare and defend themselves.

Please join Gibson Dunn for a 90-minute discussion of the latest developments in FCA, including:

  • The latest trends in FCA enforcement actions and associated litigation involving drug and device manufacturers;
  • Updates on the Trump Administration’s approach to FCA enforcement;
  • Notable legislative and administrative developments affecting the FCA’s statutory framework and application; and
  • The latest developments in FCA case law following the Supreme Court’s Escobar decision.

View Slides (PDF)

PANELISTS:

Stuart Delery is a partner in the Washington, D.C. office. He represents corporations and individuals in high-stakes litigation and investigations that involve the federal government across the spectrum of regulatory litigation and enforcement. Previously, as the Acting Associate Attorney General of the United States (the third-ranking position at the Department of Justice) and as Assistant Attorney General for the Civil Division, he supervised the DOJ’s enforcement efforts under the FCA, FIRREA and the Food, Drug and Cosmetic Act.

Marian J. Lee is a partner in the Washington, D.C. office, where she provides FDA regulatory and compliance counseling to life science and health care companies. She has significant experience advising clients on FDA regulatory strategy, risk management, and enforcement actions. She regularly advises companies during FDA inspections and investigations, and she has led an array of regulatory assessments for mergers, acquisitions, and other transactions involving FDA-regulated entities.

John Partridge is a partner in the Denver office. He focuses on white collar defense, internal investigations, regulatory inquiries, corporate compliance programs, and complex commercial litigation. He has particular experience with the FCA and the FCPA, including advising major corporations regarding their compliance programs.

Jonathan Phillips is a senior associate in the Washington, D.C. office, where his practice focuses on FDA and health care compliance, enforcement, and litigation, as well as other government enforcement matters and related litigation. He has substantial experience representing pharmaceutical, medical device, and health care provider clients in investigations by the DOJ, FDA, and Department of Health and Human Services Office of Inspector General. Previously, he served as a Trial Attorney in the Civil Division, Fraud Section of the DOJ, where he investigated and prosecuted allegations of fraud against the U.S. under the FCA and related statutes.