Category: Government Enforcement
Regulator Panel at FDLI’s Advertising & Promotion Conference
The Food and Drug Law Institute (FDLI) is hosting its annual Advertising & Promotion Conference for the Pharmaceutical, Medical Device, Biologic & Veterinary Medicine Industries this week in Washington DC. The conference kicked off this morning with the highly anticipated Food and Drug Administration (FDA) regulator panel that included Thomas […]
Resource Launch: Introducing Cooley’s HIPAA Privacy and Security Enforcement Tracking Chart
Today, we added an exciting new resource to our blog: a tracking chart that provides an overview of select privacy and security settlements related to the Health Insurance Portability and Accountability Act (HIPAA). Included in the tracking chart are summaries of allegations, settlement amounts, descriptions of corrective action plans, and […]
Two Oregon HCPs Settle with DOJ for Failing to Disclose Relationships with Industry
Earlier this month it was reported that two Oregon physicians entered into settlement agreements with the Oregon Department of Justice (DOJ) for failing to inform their patients of relationships with a medical device manufacturer. The civil action was brought by the Oregon DOJ under the Oregon Unlawful Trade Practices Act. The physicians […]
Mobile Doctors Charged with Health Care Fraud
The Department of Justice (DOJ) and Federal Bureau of Investigation (FBI) announced that the CEO of Mobile Doctors USA LLC was arrested and charged with health care fraud and one physician associated with Mobile Doctors was arrested and charged with making false statements related to health care benefits. Additionally, search warrants were executed at Mobile […]
LITIGATION ROUND-UP
Settlements On July 24, 2013, GlaxoSmithKline (GSK) announced a settlement in principle with the Attorneys General of eight states related to the development and marketing of Avandia and a separate settlement with the Attorney General of Louisiana totaling $229 million. GSK previously paid $3 billion to settle civil and criminal allegations related to the marketing of Avandia and […]
Grassley Letter to Walgreens Expresses Interest in 340B Contract Pharmacy Arrangments
On July 31, 2013, Senator Chuck Grassley (R-IA), Ranking Member of the Senate Judiciary Committee, sent a letter to Walgreens, Inc., requesting additional information about the pharmacy chain’s participation as a contract pharmacy in the 340B Drug Discount Program. While the letter does not allege any wrongdoing by Walgreens, it […]
Wyeth’s $491 Million Fraud Settlement
The U.S. Department of Justice (DOJ) announced on July 30, 2013 that it had reached a settlement with Wyeth Pharmaceuticals to resolve criminal and civil liability related to the unlawful marketing of its prescription drug Rapamune for uses not approved by the U.S. Food and Drug Administration (FDA) that caused false claims to be submitted […]
LITIGATION ROUND-UP
Settlements The U.S. Department of Justice (DOJ) announced on July 18, 2013 that pharmaceutical manufacturer Mallinckrodt LLC agreed to pay $3.5 million to settle a civil False Claims Act suit. The complaint alleged that Mallinckrodt paid illegal kickbacks to health care professionals in the form of speaker honoraria, clinical trials funding, and honoraria […]
