The U.S. export control system has undergone major reform in recent years, and companies have experienced both increased enforcement of export control laws and fines for violations, with more changes on the way. Skadden...more
1/19/2016
/ Acquisitions ,
Bureau of Industry and Security (BIS) ,
Criminal Prosecution ,
Defense Contracts ,
Department of Justice (DOJ) ,
Directorate of Defense Trade Controls (DDTC) ,
Enforcement Actions ,
Export Administration Regulations (EAR) ,
Export Controls ,
Exports ,
ITAR ,
Personal Liability ,
Policy Violations ,
Successor Liability
On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more
12/15/2015
/ Anti-Kickback Statute ,
Attorney General ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
Medicare Fraud Strike Force ,
Pharmaceutical Industry
Three years ago, in United States v. Caronia, the U.S. Court of Appeals for the Second Circuit held that the Federal Food, Drug and Cosmetic Act (FDCA) neither prohibits nor criminalizes truthful, nonmisleading speech that...more
9/29/2015
/ Advertising ,
Amarin ,
Caronia ,
Commercial Speech ,
Corporate Counsel ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Advertising ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Medical Devices ,
Misleading Impressions ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Popular ,
Product Labels ,
Ripeness ,
Warning Letters
On September 9, 2015, the Department of Justice (the Department) publicly announced that it had issued guidance to its criminal and civil prosecutors that purports to change, at least in part, the Department’s approach to...more
9/16/2015
/ Civil Investigation Demand ,
Civil Monetary Penalty ,
Cooperation Agreement ,
Corporate Crimes ,
Corporate Investigations ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
FIRREA ,
Government Investigations ,
Personal Liability ,
White Collar Crimes ,
Willful Misconduct ,
Yates Memorandum
On May 26, 2015, the U.S. Supreme Court issued a rare unanimous decision in a False Claims Act (FCA) case that cuts both ways for the health care industry. In an opinion authored by Justice Samuel Alito, the Court held in...more
While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more
6/26/2013
/ Affordable Care Act ,
Criminal Prosecution ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
FBI ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
OIG ,
Pharmaceutical Industry
In a much-anticipated opinion, the U.S. Court of Appeals for the Second Circuit vacated and remanded the conviction of Alfred Caronia, a former pharmaceutical sales representative convicted of conspiring to introduce a...more