Tag: investigation

OIG Releases Criteria for Implementing Exclusion Authority

On April 18, 2016, the Health and Human Services Office of Inspector General (OIG) released updated guidance related to the criteria it may use for evaluating its permissive exclusion authority under Section 1128(b)(7) of the Social Security Act. This guidance replaces guidance previously released by the OIG in 1997. All of […]

Class Action Following Health Information Data Breach

As we discussed in our previous post, Premera Blue Cross (Premera) recently revealed that it suffered a massive data breach potentially exposing the personal data of 11 million customers.  On Thursday Premera was hit with a proposed class action lawsuit in Washington federal court accusing it of negligence associated with the […]

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 […]

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 […]

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 […]

Resource Launch: Introducing Cooley’s Government Settlements Tracker

Cooley has added an exciting new resource to our blog: the Government Settlements Tracker.  This tracking chart provides an overview of select government settlements related to pharmaceutical, biotechnology and medical device manufacturers, including the settlement amount, whether the matter is civil and/or criminal, whether the matter resulted from a whistleblower action, resolution of the matter, and […]