Join us for our free webinar with Sidley on Wednesday, June 8 to better understand the current device enforcement landscape in the Biden administration.
What are the medical device enforcement priorities of the Biden administration? What priorities will the Department of Justice (DOJ) have? Join us for our free webinar with Sidley on Wednesday, June 8 to better understand the current device enforcement landscape during this administration. Don’t miss this opportunity to catch up on recent developments and earn 1 Continuing Legal Education (CLE) credit through Sidley. The webinar will also cover recent DOJ enforcement risk areas and how recent regulatory reforms provide defensive opportunities in enforcement actions.
Learning Objectives:
- Understand current FCA enforcement landscape, including metrics relating to length of time to resolve FCA cases and settlement values
- Review major FCA settlements from the past year involving medical device companies
- Understand the role that DOJ’s Consumer Protection Branch plays in health care enforcement
- Identify emerging enforcement trends, including cybersecurity, targeting of alleged kickbacks in commercial arrangements, and acquired compliance risks through M&A activity
Panelists
Brenna E. Jenny, Food, Drug, and Medical Device Compliance and Enforcement Healthcare, White Collar: Government Litigation and Investigations
Brenna Jenny leverages her experience in senior roles both within the U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) Civil Division to represent clients in the healthcare industry in government enforcement actions, internal investigations, and compliance reviews. Brenna has been recognized by Law360 as a “Rising Star” in Healthcare (2021). Brenna previously served as the Principal Deputy General Counsel at HHS and the Chief Legal Officer for the Centers for Medicare & Medicaid Services (CMS). In that role, Brenna supervised an unprecedented wave of regulatory flexibilities during the COVID-19 pandemic and served as the principal legal adviser to the $178 billion CARES Act Provider Relief Fund. Before joining Sidley, Brenna clerked for the Honorable Raymond W. Gruender of the Eighth Circuit Court of Appeals. Brenna received her law degree and Masters in Public Health in a joint degree program from Harvard University.
Jamie L.M. Jones, Food, Drug, and Medical Device Compliance and Enforcement Healthcare, White Collar: Government Litigation and Investigations
Jenna Jones is global co-leader of the firm’s Healthcare practice, a member of the Global Life Sciences Leadership Council, and serves on the firm’s COVID-19 Task Force. Jaime draws on her extensive experience defending healthcare and life sciences companies in government investigations and enforcement actions to provide legal and compliance organizations and Boards of Directors with strategic, practical advice to manage enforcement actions, litigation, and regulatory risk. Prior to joining the firm, Jaime clerked for the Hon. Gerald B. Tjoflat, United States Court of Appeals for the Eleventh Circuit, from 2001–2002. Jaime is among the top healthcare lawyers in the United States and is consistently ranked in Chambers as a leading lawyer. In Chambers 2021, she was recognized as being “steeped in both regulatory and legal knowledge” and “prepared to share her experience and make practical recommendations.” Jaime received her J.D. in 2001 with high honors from Duke University School of Law, and her B.A., cum laude, from the University of Notre Dame.
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