False Claims Act Liability for Regulatory Noncompliance - Webinar CD/Transcript

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False Claims Act Liability for Regulatory Noncompliance: An Update for Drug and Device Manufacturers

The Department of Justice’s interim final rule virtually doubles penalities for those that violate the False Claims Act.

How can you avoid liability under the FCA?

Anna Laakmann — Counsel, Greenberg Traurig — explains how regulatory noncompliance can form the basis of an FCA enforcement action by the government. She’ll highlight areas of regulatory risk and discuss key developments about the implied certification theory of FCA liability.

After listening to this session you will know:

  • What the False Claims Act is and how it applies to drug and device manufacturers
  • Common scenarios in which regulatory violations can give rise to FCA liability
  • What a qui tam action is and the role that employees and other whistleblowers play in enforcing the FCA against drug and device manufacturers
  • How to avoid FCA claims based on promotion and marketing
  • Implications of the Supreme Court’s recent decision in Universal Health Services v. Escobar

Order today and remain in compliance with the interim final rule of the FCA.

  • Compliance Professionals
  • Quality Professionals
  • Sales & Marketing Teams
  • Regulatory Affairs
  • Contractors/Subcontractors
  • Auditors
  • Consultants/service providers
  • Executive management
  • General/corporate counsel
  • Investigators
  • Managers
  • Manufacturing directors and supervisors
  • Personnel new to the industry
  • Pharmaceutical and cGMP auditors
  • Regulatory/legislative affairs professionals
  • Risk management specialists
  • Strategic planning and business development staff

Anna B. Laakmann, of Counsel at Greenberg Traurig, focuses her practice on litigation and regulatory matters for pharmaceutical, medical device, and life sciences companies. Before joining the firm, Anna was an associate professor at Lewis & Clark Law School, where she taught medical technology law, bioethics and public health law, intellectual property survey, patent law and policy and property. Anna has written and spoken extensively on the impact of civil litigation and government regulation on scientific research and the practice of medicine.