Tag: settlement

Advocate Data Breaches Result in Largest HIPAA Settlement To Date

On August 8th, 2016, the U.S. Department of Health and Human Services (HHS) Office of Civil Rights (OCR) issued the largest Health Insurance Portability and Accountability Act (HIPAA) settlement to date with Advocate Health Care System (Advocate).  Advocate agreed to pay $5.55 million to settle a variety of HIPAA violations.  Advocate […]

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 […]

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 […]

Health System Agrees to Pay $800,000 following Improper Disclosure of Medical Records

This week, Parkview Health System, Inc. (“Parkview”) agreed to pay $800,000 and enter into a Corrective Action Plan to settle allegations that Parkview violated the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  In 2008, Parkview took custody of between 5,000 and 8,000 medical records of patients for a retiring physician in order […]

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 […]

County Pays $215,000 to Resolve Alleged HIPAA Non-Compliance

On March 7, 2014, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) announced that Skagit County, Washington, has agreed to pay $215,000 and enter into a three year corrective action plan in order to settle alleged violations of the Health Insurance Portability and Accountability Act […]

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 […]

Johnson & Johnson Finalizes $2.2 Billion Government Settlement

Earlier this week, the U.S. Department of Justice (DOJ) announced that it reached a settlement with Johnson & Johnson (J&J) and two of its subsidiaries — Janssen Pharmaceuticals and Scios Inc. — to resolve civil and criminal health care fraud allegations. The settlement in principle was first announced by J&J […]

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 […]