BEN CORREA’s practice focuses on defending against government enforcement actions and providing strategic, practical advice on managing enforcement, litigation, and regulatory risks facing life science companies and investors. He has extensive experience representing pharmaceutical, biotech, medical device, and healthcare clients in a wide range of different regulatory and enforcement areas including:
Ben’s extensive experience serving life science clients includes:
- Department of Justice investigations alleging False Claims Act (FCA), Anti-Kickback Statute (AKS), Foreign Corrupt Practices Act (FCPA), off-label promotion, environmental statute violations, and Good Manufacturing Practices (GMP) violations (including securing several declinations)
- False Claims Act litigation related to donations to independent foundations, speaker programs, educational events, off-label promotion, and manufacturing violations
- Internal investigations covering allegations related to clinical trials, off-label promotion, data integrity, GMP violations, bribery and fraud
- Transaction due diligence and post-closing compliance integration and risk assessment covering anti-corruption, vendor management, kickback, quality assurance compliance, and financial controls compliance
- Counseling on corporate compliance program development and best practices, including risk assessments, program reviews, employee training and policy/procedures
- FDA inspections, including preparation, inspection management, and responding to 483s and Warning Letters
Ben’s practice also includes significant work with healthcare-focused third party logistics providers and distribution companies as well as cross-border matters in Europe, Asia, and Latin America.
Ben also has a significant pro bono practice and recently secured the release of inmate convicted as a juvenile who had served 24 years of an effective life sentence.