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We rigorously defend companies and individuals facing allegations of wrongdoing, government investigations, and criminal charges in connection with complex healthcare statutes.

In recent years, U.S. federal and state agencies have significantly increased their investigations and prosecutions of pharmaceutical, medical device, and life sciences companies for various forms of healthcare fraud. Healthcare fraud enforcement will continue to take center stage as a result of enhanced coordination between U.S. federal and U.S. state agencies, growing disclosure requirements under various U.S. federal statutes and regulatory schemes, the use of non-healthcare-related statutes (such as the U.S. Foreign Corrupt Practices Act and the False Claims Act) to further enforcement priorities, and the emergence of more aggressive investigation and prosecution tactics.

We regularly represent companies and individuals in the healthcare industry who face allegations of wrongdoing, government investigations, criminal charges, and related civil litigation in connection with the U.S. Food, Drug, and Cosmetic Acts, the U.S. Anti-Kickback Statute, and other U.S. healthcare statutes. These representations range from conducting internal investigations and quietly guiding clients through government investigations – thereby helping them minimize disruption to their business and avoid charges – to vigorous defense in court.

We have represented numerous companies and individuals in connection with the U.S. government’s continued enforcement of “off-label” (not approved by the U.S. FDA) promotion of drugs and devices. We are well-versed in the various practices that government prosecutors and regulators believe constitute off-label promotion.