Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
9/9/2021
/ Criminal Investigations ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Falsified Documents ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Product Defects ,
Qui Tam ,
Whistleblowers
Enforcement in Life Sciences Series: Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers About the Enforcement in Life Sciences Series Recent settlements between the U.S. Department of...more
Enforcement in Life Sciences Series:
Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers -
Recent settlements between the U.S. Department of Justice (DOJ) and a range of...more
Enforcement in Life Sciences Series:
Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers -
About the Enforcement in Life Sciences Series -
Recent settlements between the U.S....more
Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more
8/24/2020
/ Anti-Kickback Statute ,
Civil Monetary Penalty ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Fines ,
Health Care Providers ,
Incentive Compensation ,
Life Sciences ,
Marketing ,
Novartis ,
OIG ,
Pharmaceutical Industry ,
Physicians ,
Popular ,
Qui Tam ,
Risk Assessment ,
Risk Mitigation ,
Salespersons ,
Settlement Agreements ,
Speaker Programs
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
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
1/24/2020
/ Anti-Kickback Statute ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare Costs ,
Imports ,
Innovation ,
Legislative Agendas ,
Life Sciences ,
Medical Devices ,
Medicare Part D ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Proposed Legislation ,
Settlement Agreements ,
State Legislatures ,
Trump Administration
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
12/2/2019
/ Anti-Kickback Statute ,
Big Data ,
CDRH ,
Charitable Organizations ,
Co-payments ,
Data Privacy ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Disgorgement ,
Drug Pricing ,
Enforcement Actions ,
False Advertising ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Lanham Act ,
Life Sciences ,
Medical Devices ,
NAD ,
Off-Label Promotion ,
OIG ,
OPDP ,
Pharmaceutical Industry ,
Physician Compensation Arrangements ,
Pleading Standards ,
POM Wonderful v Coca Cola ,
REMS ,
RICO ,
Risk Assessment ,
Risk Management ,
SCOTUS ,
Tobacco
In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more
1/18/2019
/ Affordable Care Act ,
Constitutional Challenges ,
Department of Justice (DOJ) ,
Deregulation ,
Digital Health ,
Drug Pricing ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance ,
Life Sciences ,
Popular ,
Tax Credits ,
Trump Administration ,
White Collar Crimes
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
12/13/2018
/ Anti-Bribery ,
Anti-Corruption ,
Anti-Kickback Statute ,
Bribery ,
Compliance ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Digital Health ,
Drug Pricing ,
Enforcement Actions ,
Ethical Standards ,
False Claims Act (FCA) ,
FDA Approval ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Internal Investigations ,
Kickbacks ,
Life Sciences ,
Materiality ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
PHRMA ,
Popular ,
Product Labels ,
Rebates ,
Safe Harbors ,
Securities and Exchange Commission (SEC) ,
Sunshine Act ,
Transparency ,
Universal Health Services Inc v United States ex rel Escobar ,
Whistleblowers
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
The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more
1/31/2018
/ Affordable Care Act ,
Block Grants ,
Centers for Medicare & Medicaid Services (CMS) ,
Children's Health Insurance Program (CHIP) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Deregulation ,
Enforcement Actions ,
Executive Orders ,
False Claims Act (FCA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Health Insurance ,
Healthcare Reform ,
Individual Mandate ,
Medicaid ,
Medical Devices ,
Medical Reimbursement Plans ,
Medicare ,
Opioid ,
Orphan Drugs ,
Political Parties ,
Popular ,
Stabilization Issues ,
Trump Administration ,
Universal Health Services Inc v United States ex rel Escobar
Panelists examined major enforcement actions from 2017 and identified key trends. Aggressive Enforcement With a Decrease in High-Dollar Settlements. Panelists noted that the Department of Justice (DOJ) continues its...more
12/5/2017
/ Anti-Kickback Statute ,
Corporate Integrity Agreement ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
First Amendment ,
Food and Drug Administration (FDA) ,
Foreign Corrupt Practices Act (FCPA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Materiality ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Patient Assistance Programs ,
Pharmaceutical Industry ,
Popular ,
Securities and Exchange Commission (SEC) ,
Universal Health Services Inc v United States ex rel Escobar
On September 22, 2017, Aegerion Pharmaceuticals resolved a wide-ranging probe by the Department of Justice (DOJ) regarding the company’s U.S. commercial activities relating to Juxtapid, a lipid-lowering agent for the...more
9/28/2017
/ Anti-Kickback Statute ,
Consent Decrees ,
Criminal Conspiracy ,
Criminal Investigations ,
Criminal Penalties ,
Deferred Prosecution Agreements ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraudulent Inducement ,
HIPAA Audits ,
HIPAA Breach ,
Medical Devices ,
Misdemeanors ,
Off-Label Promotion ,
Pharmaceutical Industry ,
Prescription Drugs ,
Promotional Items ,
Whistleblowers
On December 6, 2016, the Supreme Court of the United States ruled unanimously in State Farm Fire and Casualty Co. v. United States ex rel. Rigsby that violations of the False Claims Act’s (FCA) seal requirement do not require...more
On June 16, 2016, the U.S. Supreme Court in Universal Health Services, Inc. v. United States ex rel. Escobar1 (Escobar) unanimously upheld the implied certification theory of False Claims Act (FCA) liability and strengthened...more
11/7/2016
/ Appeals ,
Conditions of Payment ,
Department of Justice (DOJ) ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Fraud ,
Government Knowledge Defense ,
Material Misrepresentation ,
Materiality ,
Motion to Dismiss ,
Pleading Standards ,
Qui Tam ,
Scienter ,
Summary Judgment ,
Universal Health Services Inc v United States ex rel Escobar
On June 16, 2016, the U.S. Supreme Court in Universal Health Services v. United States ex rel. Escobar unanimously upheld the implied certification theory of False Claims Act (FCA) liability. The Court ruled that a party can...more
6/17/2016
/ Conditions of Payment ,
False Claims Act (FCA) ,
False Implied Certification Theory ,
Federal Contractors ,
Fraud ,
Implied Certification ,
Material Misrepresentation ,
Materiality ,
Medicaid ,
Medicare ,
Mental Health ,
SCOTUS ,
Universal Health Services Inc v United States ex rel Escobar ,
Unlicensed Medical Providers
The Office of Inspector General of the Department of Health and Human Services (OIG) has issued updated guidance on the use of its so-called permissive exclusion authority under Section 1128(b)(7) of the Social Security Act...more
4/22/2016
/ Administrative Authority ,
Centers for Medicare & Medicaid Services (CMS) ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Exclusion Orders ,
False Claims Act (FCA) ,
Federal Health Care Programs (FHCP) ,
Fraud and Abuse ,
New Guidance ,
OIG ,
Risk Assessment ,
Willful Misconduct
On March 22, 2016, the U.S. Supreme Court issued a decision in the Fair Labor Standards Act (FLSA) class action Tyson Foods, Inc. v. Bouaphakeo. In an opinion authored by Justice Anthony Kennedy, the majority held that class...more
4/5/2016
/ Admissible Evidence ,
Class Action ,
Department of Justice (DOJ) ,
Fair Labor Standards Act (FLSA) ,
False Claims Act (FCA) ,
Health Care Providers ,
Relators ,
SCOTUS ,
Statistical Sampling ,
Tyson Foods v Bouaphakeo ,
Wage and Hour
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
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
Executive Summary -
On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more