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
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
As health organizations and governments around the world work to contain the coronavirus (COVID-19), businesses should be mindful of the various ways the virus may impact their operations and employees. The wide range of...more
3/5/2020
/ Acquisitions ,
Anti-Discrimination Policies ,
Business Interruption ,
Capital Markets ,
Centers for Disease Control and Prevention (CDC) ,
Commercial Contracts ,
Coronavirus/COVID-19 ,
Corporate Restructuring ,
Cybersecurity ,
Derivatives ,
Disclosure Requirements ,
Employment Policies ,
Equity Securities ,
Force Majeure Clause ,
Global Economy ,
Leveraged Finance ,
Life Sciences ,
Mergers ,
OSHA ,
Popular ,
Public Health ,
Public Safety ,
Publicly-Traded Companies ,
Securities and Exchange Commission (SEC) ,
Securities Litigation ,
Supply Chain ,
Virtual Meetings
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
At the close of 2018, the Advanced Medical Technology Association (AdvaMed) released an updated version of its Code of Ethics governing medical technology manufacturers in their interactions with health care professionals...more
2/1/2019
/ AdvaMed ,
Consultants ,
Continuing Medical Education ,
Donations ,
Employee Training ,
Ethics ,
Good Clinical Practices ,
Grants ,
Health Care Providers ,
Health IT ,
Healthcare Workers ,
Meals-Gifts-and Entertainment Rules ,
Medical Devices ,
Off-Label Promotion ,
Sponsorship Agreements ,
Technology Sector ,
Traveling Employee
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
While the number of new corporate integrity agreements (CIAs) declined since last year, and was below the trailing five-year average, 2018 was an important year on the policy front for the Office of Inspector General (OIG),...more
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 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