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
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
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
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
4/22/2021
/ Anti-Kickback Statute ,
Compliance ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health Care Providers ,
Life Sciences ,
Medical Devices ,
Novartis ,
OIG ,
Pharmaceutical Industry ,
Sunshine Act
Despite the challenges posed by the COVID-19 public health emergency in 2020, the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) entered into the highest number of corporate integrity...more
On November 16, 2020, the Office of the Inspector General of the Department of Health and Human Services (HHS-OIG) issued a Special Fraud Alert regarding the inherent fraud and abuse risks associated with...more
11/25/2020
/ Coronavirus/COVID-19 ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Fraud Alerts ,
Health Care Providers ,
Healthcare Fraud ,
Life Sciences ,
OIG ,
Pharmaceutical Industry ,
Speaker Programs
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
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
7/15/2020
/ Coronavirus/COVID-19 ,
Domestic Corporations ,
Food and Drug Administration (FDA) ,
Foreign Corporations ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Rating System ,
Re-Opening Guidelines ,
Risk Assessment ,
Safety Inspections ,
Tobacco Regulations
On June 8, 2020, the Food and Drug Administration (FDA or Agency) issued temporary guidance to address concerns related to distribution of drug samples during the COVID-19 public health emergency....more
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
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
1/30/2020
/ Acquisitions ,
Administrative Procedure Act ,
Anti-Discrimination Policies ,
Anti-Harassment Policies ,
Anti-Kickback Statute ,
Antitrust Investigations ,
Appeals ,
Arbitration Awards ,
Attorney General ,
Backstop Agreements ,
BEPS ,
BitLicense ,
Blockchain ,
Board of Directors ,
Bonds ,
Capital Markets ,
CFIUS ,
CFTC ,
Chapter 11 ,
Claim Preclusion ,
Class Action ,
Commercial Bankruptcy ,
Common Stock ,
Congressional Investigations & Hearings ,
Congressional Subpoenas ,
Consumer Financial Protection Bureau (CFPB) ,
Cooperation Agreement ,
Copyright ,
Corporate Governance ,
Corporate Restructuring ,
Corporate Social Responsibility ,
Corporate Taxes ,
Corwin Doctrine ,
Covenant Lite Deals ,
Creditors ,
Cross-Border Transactions ,
DACA ,
DE Supreme Court ,
Debt Financing ,
Debtors ,
Department of Justice (DOJ) ,
Dischargeable Debts ,
Disgorgement ,
Disparate Impact ,
Dodd-Frank ,
Down Rounds ,
Drug Pricing ,
EBITDA ,
Employee Retirement Income Security Act (ERISA) ,
Employer Liability Issues ,
Employment Discrimination ,
Enforcement Actions ,
Enforcement of Foreign Judgments ,
Enterprise Act 2002 ,
Environmental Social & Governance (ESG) ,
EU ,
Fair Housing Act (FHA) ,
Federal Trade Commission (FTC) ,
FinTech ,
FIRRMA ,
Foreign Acquisitions ,
Foreign Investment ,
Foreign Issuers ,
FRCP 23 ,
General Data Protection Regulation (GDPR) ,
General Elections ,
GILTI tax ,
High-Yield Markets ,
Hong Kong ,
Hong Kong Stock Exchange ,
Individual Accountability ,
Initial Public Offering (IPO) ,
Intellectual Property Litigation ,
Intercreditor Agreements ,
International Arbitration ,
International Litigation ,
IRS ,
Issue Preclusion ,
Japan ,
Joint Venture ,
Legislative Agendas ,
Life Sciences ,
Listing Rules ,
Litigation Strategies ,
Make-Whole Premium ,
Mergers ,
MFW ,
Multinationals ,
National Security ,
PCAOB ,
Pharmaceutical Industry ,
Political Parties ,
Preferred Shares ,
Private Offerings ,
Privately Held Corporations ,
Proxy Advisory Firms ,
Publicly-Traded Companies ,
Refinancing ,
Regulatory Agenda ,
Reporting Requirements ,
SCOTUS ,
Securities and Exchange Commission (SEC) ,
Securities Litigation ,
Separation of Powers ,
Shareholder Activism ,
Shareholder Proposals ,
Shareholders ,
Split of Authority ,
State Labor Laws ,
Stock Drop Litigation ,
Tax Cuts and Jobs Act ,
Tax Litigation ,
Technology Sector ,
Third-Party Release Agrements ,
Transparency ,
UK ,
UK Brexit ,
Valuation ,
White Collar Crimes
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
Corporate integrity agreements (CIAs) continued to be an important tool for the Office of Inspector General, U.S. Department of Health and Human Services (HHS-OIG) in 2019. Notably, pharmaceutical and device manufacturers saw...more
1/21/2020
/ Corporate Integrity Agreement ,
Corporate Misconduct ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Employee Misconduct ,
Enforcement Actions ,
Health Care Providers ,
Healthcare Fraud ,
Medical Devices ,
OIG ,
Pharmaceutical Industry
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
The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more
2/5/2019
/ Amended Rules ,
Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Health Care Providers ,
Health Plan Sponsors ,
Manufacturers ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
OIG ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Public Comment ,
Rebates ,
Safe Harbors
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
2017 was slightly above average for new corporate integrity agreements (CIAs), with 46 entered into by the Department of Health and Human Services’ (HHS) Office of Inspector General (OIG) and companies and individuals...more
3/26/2018
/ Charitable Organizations ,
Civil Monetary Penalty ,
Compliance ,
Corporate Integrity Agreement ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Health IT ,
Healthcare Fraud ,
Medical Devices ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Settlement ,
Vendors
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
While President Donald Trump made repeal of the Affordable Care Act (ACA) a centerpiece of his 2016 presidential campaign, he offered few details about how he would replace it or address other health care issues. More...more
2/4/2017
/ Administrative Appointments ,
Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Fraud Abuse and Waste ,
Health Insurance ,
Health Savings Accounts ,
Healthcare Fraud ,
Healthcare Reform ,
Innovation ,
Legislative Agendas ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Repeal ,
Tax Credits ,
Trump Administration
On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more
2/2/2017
/ Administrative Authority ,
Draft Guidance ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Free Speech ,
Life Sciences ,
Medical Devices ,
Off-Label Promotion ,
Pharmaceutical Industry
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
12/14/2016
/ 21st Century Cures Initiative ,
Barack Obama ,
Cancer ,
Civil Monetary Penalty ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Federal Funding ,
Food and Drug Administration (FDA) ,
HCEI ,
Health Information Technologies ,
Healthcare Fraud ,
Hospitals ,
Infectious Diseases ,
Innovation ,
Life Sciences ,
Medical Devices ,
Medical Research ,
Mental Health ,
National Institute of Health (NIH) ,
New Legislation ,
Opioid ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Safe Harbors ,
Software Developers
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
In an apparent first, the U.S. Food and Drug Administration (FDA) has conceded that a pharmaceutical company may engage in truthful and nonmisleading speech promoting the off-label use of a prescription drug. This concession...more