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False Claims Act - 2023 Year in Review

As we do every year, this issue revisits the key cases and other developments from the year gone by. And by most metrics, 2023 was a notable year for the False Claims Act (FCA). We start with the numbers: The Department...more

SCOTUS to Decide Constitutional Fate of SEC’s In-House Courts

The U.S. Supreme Court will decide whether the Securities and Exchange Commission’s (SEC) in-house enforcement proceedings violate the Constitution, teeing up a decision that could curtail securities law enforcement and...more

False Claims Act - 2022 Year in Review

In 2022, the False Claims Act (FCA) continued to be the federal government’s chief tool for combatting fraud. Many trends in recent years were likewise present in 2022: robust FCA enforcement generally, healthcare as the...more

False Claims Act - 2021 Year in Review

The year 2021 marks the 10th anniversary of the Bradley False Claims Act Year in Review. In that decade, much has remained the same in FCA enforcement. To start with the obvious: It continues to result in billions of dollars...more

False Claims Act 2020 Year in Review

This year saw substantial activity in FCA settlements and litigated court cases. Although no single case or development dominated the discourse this year, several important court decisions were issued, including two that may...more

False Claims Act: 2018 Year in Review

INTRODUCTION - Unlike some recent years, 2018 was somewhat short on headline grabbing news related to the False Claims Act (FCA). There were, to be sure, significant developments in the courts and within the Department of...more

Averting Government Scrutiny in the Wake of an Opioid Prescribing Crackdown - Practical Pain Management

The scourge of opioid-related addiction and risk is a well-known story among the pain management community. In response to this federally declared public health crisis, government prosecutors are upping their game. Almost...more

Scrutiny Increases on Healthcare Providers in Central Florida

In the past month, the U.S. Attorney's Office for the Middle District of Florida--the primary federal law enforcement authority in Central Florida--has announced a series of healthcare-fraud related developments. These...more

Investor, Beware: New Prosecutorial Scrutiny of Private Equity Investment in Healthcare Companies

A bedrock principle of private equity investment is that investors expect to make money on their investments. A recent lawsuit by the Department of Justice (DOJ), however, might force private equity investors in healthcare to...more

Designing Clinical Studies To Avoid Regulatory Scrutiny

Practical advice following the Primex Clinical Laboratories settlement - Earlier this year, the Department of Justice (DOJ) announced a $3.5 million settlement against Primex Clinical Laboratories, a California laboratory...more

New DOJ Guidance Portends New Defenses in False Claims Act Cases

Last week, the Department of Justice (DOJ) issued two separate memoranda with potentially far-reaching consequences. While the practical effect of these documents remains to be seen, they may provide another avenue of...more

False Claims Act: 2017 Year in Review

Bradley’s Government Enforcement and Investigations practice group is pleased to present the 2017 False Claims Act Year in Review, our annual review of significant False Claims Act (FCA) cases, developments, and trends. The...more

The Giving Season Is Over: Practical Advice for Patient Assistance Programs in the Wake of United Therapeutics’ $210 Million False...

Right before Christmas last year, the Department of Justice (DOJ) announced an ominous settlement: United Therapeutics, a manufacturer of pulmonary arterial hypertension drugs, agreed to pay more than $200 million to settle...more

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