Life Sciences and Healthcare Investigations and Litigation
We have deep experience handling internal investigations and helping life sciences and healthcare clients avoid, and, if necessary, defend government investigations. We have represented companies on-site during extended hostile inspections of multiple facilities, conducted numerous sensitive internal investigations, been the clients' first call during law enforcement raids and seizures, managed high-profile congressional inquiries, and represented clients in complex fraud and abuse and scientific misconduct matters. We have also negotiated landmark resolutions of cases with FDA and the Department of Justice, corporate integrity agreements with the Department of Health and Human Services (HHS) Office of Inspector General (OIG), and settlements with state regulators. We also routinely sue the government to defend our client's legal rights, from First Amendment challenges to state suits on drug-pricing mandates.
Managing Complexity: Our team has had success in numerous matters involving simultaneous multiagency and congressional investigations involving complex allegations requiring deep knowledge of industry practices and applicable law.
Proactive Approach: We routinely assist clients in developing corrective action plans for various types of regulatory noncompliance, and a major aspect of our practice involves proactive compliance reviews and audits intended to reduce risks and avoid enforcement.
Understanding Emerging Theories: Our team tracks virtually every enforcement matter in the life sciences and healthcare fields, analyzing emerging theories and trends in government enforcement that could impact our clients.