Tag: FCA

LITIGATION ROUND-UP: SOME RECENT DRUG & DEVICE SETTLEMENTS, INVESTIGATIONS, INQUIRIES

Settlements Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies, promoted its antidepressants for unapproved uses, and misrepresented its drug prices to state Medicaid programs.  The settlement resolved two False Claims Act […]

DOJ Announces Recently Implemented Procedure for Reviewing False Claims Act Suits for Criminal Prosecution

During a speech at the annual Taxpayers Against Fraud Education Fund conference this week, Assistant Attorney General Leslie R. Caldwell announced that the U.S. Department of Justice’s (DOJ) Criminal Division “recently implemented a procedure so that all new qui tam complaints are shared by the Civil Division with the Criminal Division as soon […]

LITIGATION ROUND-UP

Settlements & Resolutions GlaxoSmithKline (GSK) agreed to pay $105 million to resolve allegations that it illegally marketed its asthma drug Advair and its antidepressants Paxil and Wellbutrin for uses not approved by the US Food and Drug Administration (FDA) in violation of state consumer protection laws.  The multi-state settlement included 44 states […]

LITIGATION ROUND-UP

Settlements BioScrip agreed to pay $15 million to settle a False Claims Act (FCA) suit alleging that it received kickbacks from Novartis Pharmaceuticals related to its distribution of Exjade through its legacy specialty pharmacy operations.  The Department of Justice (DOJ) alleged that Novartis directed BioScrip to increase patient refills on Exjade and, over the next several years as BioScrip increased its Exjade refill […]

Government’s Annual Health Care Fraud Results Released: $4.3 Billion Recovered in 2013

The Department of Health and Human Services (DHHS) and The Department of Justice (DOJ) Health Care Fraud and Abuse Control (HCRAC) Program Annual Report for Fiscal Year 2013 (Report) was released this week.  The Report states that the DHHS and DOJ recovered $4.3 billion in health care fraud judgments and settlements in fiscal year 2013.  […]

LITIGATION ROUND-UP

Settlements The U.S. Department of Justice (DOJ) announced on Friday that it reached a nearly $5.5 million settlement with Abbott Laboratories to resolve allegations that it violated the False Claims Act by paying kickbacks to induce doctors to implant the company’s carotid, biliary and peripheral vascular products.  The alleged kickbacks […]

Government Enforcement Presentations at Pharmaceutical Industry Conference

The government enforcement presentations are highly anticipated events by industry attendees at the Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum (PCF).  This year’s agenda included a presentation by Mary Riordan of the U.S. Department of Health and Human Services Office of Inspector General (“OIG”), followed by an assistant U.S. Attorney (AUSA) […]