Epstein Becker Green attorneys successfully executed a very favorable settlement for their client, AtriCure Inc., in a False Claims Act (FCA) case that began with a qui tam relator’s charges filed in 2007. AtriCure is a developer and manufacturer of cardiac surgical ablation devices.
This case presented sophisticated claims relating to alleged improper off-label promotion. This is an issue that has become a high priority for Department of Justice enforcement of which both drug and device manufacturers and distributors should be aware.
The settlement, based on an ability-to-pay methodology accepted by the government, requires AtriCure to pay total of $3.8 million, plus interest, periodically over five years; resolves issues of potential FCA and common law violations relating to the marketing practices of AtriCure’s surgical ablation devices; and includes AtriCure’s declaration that the company and its employees haven’t engaged in any wrongdoing or illegal activity. The settlement agreement has been approved and resolves a related qui tam matter, which Epstein Becker Green attorneys have been handling, regarding AtriCure’s marketing of the devices. Additionally, AtriCure signed a corporate integrity agreement with the Office of Inspector General of the U.S. Department of Health and Human Services.