Advanced BioHealing (Shire) Settlement Largest in Medical Device History

Earlier this month, the Department of Justice (DOJ) announced that Shire Pharmaceuticals LLC and other subsidiaries of Shire plc will pay $350 million to settle federal and state False Claims Act (FCA) allegations that Shire and Advanced BioHealing (ABH) – a company Shire acquired in 2011 – employed kickbacks and other unlawful methods to induce clinics and physicians to use or overuse its product Dermagraft, a bioengineered human skin substitute approved by the Food and Drug Administration (FDA) for the treatment of diabetic foot ulcers. The DOJ initiated both civil and criminal investigations in June 2011, with U.S. attorneys in Florida and Washington, D.C., participating in the process. Shire mentioned the investigation two-and-a-half years later when it sold off Dermagraft at a loss of $650 million, saying that it would retain the liabilities of the investigation. The proposed settlement, if finalized, will be the second that Shire has reached with the government over FCA violations in as many years. The allegations resolved by the settlements were brought in six separate lawsuits filed under the qui tam provisions of the FCA, all of which were either filed or transferred to the U.S. District Court for the Middle District of Florida. The matters were investigated by a wide array of stakeholders, including: the Civil Division’s Commercial Litigation Branch; the U.S. Attorneys’ Offices for the Middle District of Florida, District of Columbia, Middle District of Te...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs