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DAG Monaco announces shift in DOJ enforcement policies - Prioritizing corporate misconduct and individual accountability

On October 28, 2021, Deputy Attorney General (DAG) Lisa O. Monaco gave the keynote address at the ABA’s 36th National Institute on White Collar Crime and announced a series of changes in the Department of Justice’s (DOJ)...more

Life Sciences and Health Care Horizons - 2021

Companies in the life sciences and health care industry, like most companies, navigated unparalleled challenges in 2020. But unlike other industries, they had to do so while simultaneously facing the biggest challenge of all...more

Aerospace and Defense - Insights Bribery and Corruption Outlook 2021

Aerospace, defense, and government services – tighter control ahead - 2020 was an eventful year for companies in the aerospace, defense, and government services (ADG) sector. The industry saw arguably the largest...more

Fifth Amendment to PREP Act Declaration expands "covered persons" to increase workforce authorized to administer COVID-19 vaccines

On January 28, 2021, the U.S. Department of Health and Human Services (“HHS”) issued its fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (“PREP Act”) related to COVID-19...more

2021 Enforcement Horizon: New administration civil and criminal enforcement efforts

With a new administration comes new policies and enforcement priorities. Today, as we kickoff our new series “2021 Enforcement Horizon,” we take notice of what has already been a very active administration, and we consider...more

Doing business in the United States

The U.S. is one of the easiest jurisdictions in the world in which to do business1 . 1 Regulatory barriers are generally low, establishing a branch or business entity is quick and easy, labor and employment laws are much...more

World Bank Investigations Arm Sets Anti-Corruption Priorities for 2021

In October, the World Bank Group (WBG) published its third Sanctions System Annual Report for Fiscal Year 2020 (FY20), which covers the period from 1 July 2019 to 30 June 2020. The report provides a detailed look at the...more

Individual prosecutions under the FCPA – more trials and more caselaw

This month’s analysis looks at individual prosecutions under the Foreign Corrupt Practices Act (FCPA). Prosecutions have markedly increased over the last five years, and this will better define local, regional, and...more

PREP Act declaration amended to clarify coverage of certain products not directly used for COVID-19

On Monday, the U.S. Department of Health and Human Services (HHS) issued a second amendment (the Amendment) to the March 10, 2020 Declaration under the Public Readiness and Emergency Preparedness (PREP) Act for Medical...more

The U.S. Department of Justice updates roadmap to an effective compliance program

On June 1, 2020, the U.S. Department of Justice (DOJ), Criminal Division, updated its guidance on the “Evaluation of Corporate Compliance Programs,” providing increased clarity on some of the key questions prosecutors will...more

Braving a perfect storm: Avoiding legal and reputational risk associated with CARES Act oversight and investigations

Businesses across the United States have been battered by the COVID-19 crisis and many companies have been the recipients of unprecedented levels of economic assistance and tax relief under the Coronavirus Aid, Relief, and...more

HHS Issues Advisory Opinion Encouraging a Broad Reading of its PREP Act Declaration

On April 14, 2020, the Department of Health and Human Services (HHS) General Counsel issued an advisory opinion (“the Opinion”) on the March 10, 2020 Public Readiness and Emergency Preparedness Act (“PREP Act”) Declaration...more

HHS guidance confers PREP Act immunity to pharmacists for certain COVID-19 tests

On April 8, 2020, the Office of Assistant Secretary for Health (OASH), in the U.S. Department of Health and Human Services (HHS) issued Guidance for Licensed Pharmacists, COVID-19 Test, and Immunity Under the PREP...more

Liability immunity under the PREP Act for COVID-19 countermeasures: what manufacturers need to know

The Secretary of HHS issued a public health emergency declaration, effective February 4, 2020, regarding COVID-19. The impact of that declaration is to trigger certain targeted liability immunity provisions under the Public...more

Roadmap for False Claims Act enforcement in 2020

Government recoveries under False Claims Act (FCA) enforcement grew slightly in fiscal year (FY) 2019 to just over $3 billion. Companies operating in the Aerospace, Defense, and Government Services (ADG) industry continue...more

2019 crisis leadership in review

What starts online won't stop there - There aren't many college basketball games that change the share price of a Fortune 100 company. But in February 2019, Duke University freshman star Zion Williamson blew out one of his...more

DOJ refines cooperation requirements of FCPA corporate enforcement policy

On November 20, 2019, the U.S. Department of Justice (DOJ) announced several subtle, but important, adjustments to its Foreign Corrupt Practices Act (FCPA) Corporate Enforcement Policy. These recent changes relate to...more

ADG Insights: Top 5 areas of False Claims Act risk for Aerospace, Defense, and Government Services companies

Through ADG Insights, we share with you the top legal and political issues affecting the Aerospace, Defense, and Government Services (ADG) industry. Our ADG industry team monitors the latest developments to help our clients...more

Eleventh Circuit Confirms: Mere Difference of Opinion Between Physicians Does Not Establish Falsity Under the False Claims Act

More than two years after the Northern District of Alabama granted summary judgment in a False Claims Act (FCA) case in favor of AseraCare Inc., holding that “contradiction based on clinical judgment or opinion alone cannot...more

U.S. and Brazilian Authorities Reportedly Cooperating in Investigation of Alleged Bribery and Price Fixing Related to Medical...

In a May 17, 2019 press report that has been widely distributed in Brazil and the United States, Brazilian Federal Prosecutor Marisa Ferrari confirmed that the U.S. Federal Bureau of Investigation (FBI), the U.S. Department...more

The Southern District of New York Expresses Concern with Government's "Outsourcing" of Corporate Internal Investigations

In a recent decision that could have critical implications for corporate internal investigations conducted pursuant to a government agency’s request, the Southern District of New York expressed concern with the government’s...more

False Claims Act: 2018 and the road ahead

The pace of False Claims Act (FCA) litigation remained furious over the past year. Companies (and individuals) in all sectors of the economy continue to face the ever-present threat of FCA enforcement whenever they do...more

DOJ aims for good, not perfect: Our view of the updated corporate cooperation policy

Government attorneys now have additional discretion in False Claims Act (FCA) civil cases to award cooperation credit to a corporation that meaningfully assists the government’s investigation without necessarily identifying...more

In fraud and corruption investigations, artificial intelligence and data analytics save time and reduce client costs

When a legal team needs to find the facts behind fraud and corruption allegations in a government investigation, technology can drive substantial new efficiencies. ...more

Japan's plea bargaining system

A new plea bargaining system – offering reduced penalties to companies that report certain violations and cooperate with government investigations – will come into effect in Japan this June, reflecting an amendment to the...more

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