Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
4/30/2020
/ Civil Monetary Penalty ,
Clinical Laboratory Testing ,
Compliance ,
Coronavirus/COVID-19 ,
Corporate Misconduct ,
Criminal Penalties ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Prosecutors ,
Health IT ,
Inducements ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Medical Technology Companies ,
Off-Label Promotion ,
Patient Safety ,
Pharmaceutical Industry ,
Product Defects ,
Sunshine Act
On December 10, 2018, Olympus Medical Systems Corporation and a former quality manager at the company pleaded guilty to introducing misbranded medical devices into interstate commerce in violation of the Federal Food, Drug...more
12/14/2018
/ Adverse Events ,
Criminal Convictions ,
Criminal Forfeiture ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Failure to Report ,
Failure-to-File ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Fines ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Interstate Commerce ,
Medical Device Reports (MDRs) ,
Medical Devices ,
Misbranding ,
Patient Safety ,
Personal Liability ,
Plea Agreements ,
Popular ,
Warning Letters
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
3/30/2018
/ Acquisitions ,
Anti-Kickback Statute ,
Biotechnology ,
Charitable Donations ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Donations ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Gilead Sciences Inc v United States ex rel Campie ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Life Sciences ,
Materiality ,
Medical Devices ,
Medicare ,
Off-Label Promotion ,
OIG ,
Park Doctrine ,
Patient Assistance Programs ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Promotional Items ,
Split of Authority ,
Universal Health Services Inc v United States ex rel Escobar ,
Warning Letters ,
Whistleblowers
On October 5, 2016, Skadden hosted its Fourth Annual Seminar for Pharmaceutical, Biotechnology and Medical Device Companies. The seminar focused on the current and developing challenges facing such companies and included...more
10/26/2016
/ Acquisitions ,
Biotechnology ,
Corporate Integrity Agreement ,
Corporate Misconduct ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Actions ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Guilty Pleas ,
Indictments ,
Kickbacks ,
Life Sciences ,
Medical Devices ,
Mergers ,
OIG ,
Omissions ,
Personal Liability ,
Pharmaceutical Industry ,
Popular ,
Securities Fraud ,
Settlement ,
Yates Memorandum
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 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