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First Circuit Demands ‘But For’ Causation Between Alleged Kickback and Claim Submission

On February 18, 2025, a panel of the U.S. Court of Appeals for the First Circuit unanimously decided that in order to transform an Anti-Kickback Statute (AKS) violation into a false or fraudulent claim for purposes of False...more

Anti-Bribery and Corruption Risks Remain Despite FCPA Enforcement Pause

On February 10, 2025, President Donald Trump signed an executive order directing the U.S. attorney general, Pam Bondi, to pause Foreign Corrupt Practices Act (FCPA) actions for 180 days until she issues revised FCPA...more

DOJ Enters First Intervention in Cybersecurity Qui Tam

The U.S. government’s recent complaint in a relator-filed case under the False Claims Act (FCA): - Marks the first FCA suit in which the Department of Justice (DOJ) has intervened since launching its ongoing Civil...more

Contractors Settle Cyber Fraud Claims Alleging Ignored Security Measures

Two recent settlements under the False Claims Act (FCA): - Signal enhanced risk around cybersecurity for recipients of federal funds. - Underscore the need to assess compliance with cybersecurity requirements and...more

Inside the Courts – An Update From Skadden Securities Litigators - May 2024

Spotlight - Macquarie Ruling Raises the Bar for Securities Fraud Claims - Key Points - - On April 12, 2024, the U.S. Supreme Court unanimously reversed and vacated the Second Circuit’s decision in Macquarie...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates - March 2024

Circuit Split Widens Over AKS-Based FCA Causation Element - The Anti-Kickback Statute (AKS) continues to form the basis of hundreds of millions of dollars of annual recoveries for the government under the federal False...more

Foreign Extortion Prevention Act Criminalizes Demand-Side Bribery

On December 22, 2023, President Biden signed into law the Foreign Extortion Prevention Act (FEPA) as part of the fiscal year 2024 National Defense Authorization Act. FEPA criminalizes demand-side bribery by foreign officials...more

The Nucleus: Life Sciences Enforcement and Regulatory Updates

In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more

Inside the Courts – An Update From Skadden Securities Litigators - September 2023

Two Sides of the Same Coin: Analyzing the Recent Ripple and Terraform Decisions - Key Points - - In July 2023, Judges Torres and Rakoff in the Southern District of New York issued rulings on whether digital asset sales...more

Supreme Court Clarifies False Claims Act Scienter Element in Schutte

On June 1, 2023, the U.S. Supreme Court issued its highly anticipated decision in the consolidated cases United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc., Nos. 21-1326 &...more

The Nucleus: Life Sciences Regulation and Enforcement Updates

We are pleased to present the first issue of our newsletter analyzing recent trends and developments impacting the life sciences industry, including DOJ policy updates and key provisions of the Food and Drug Omnibus Reform...more

SCOTUS Unanimously Endorses Early Challenge to Agency Proceedings, Limiting Enforcement Agency Power

The Supreme Court has made it easier to challenge the constitutionality of administrative tribunals housed at federal agencies. On April 14, 2023, the Court unanimously held in Axon Enterprise, Inc. v. Federal Trade...more

DOJ Implements Voluntary Self-Disclosure Policy for US Attorneys’ Offices

On February 22, 2023, the Department of Justice (DOJ) adopted a new policy that establishes a national standard for voluntary self-disclosure credit in corporate criminal enforcement actions brought by U.S. Attorneys’ Offices...more

DOJ Doubles Down on Efforts To Incentivize Early Self-Reporting and Cooperation

On January 17, 2023, the U.S. Department of Justice (DOJ) announced revisions to the Criminal Division’s Corporate Enforcement Policy. The revisions follow Deputy Attorney General (DAG) Lisa Monaco’s September 2022...more

Inside the Courts – An Update From Skadden Securities Litigators - December 2022

Cornerstone Research reports that during the first six months of 2022, plaintiffs filed 110 securities class actions, a pace that is generally in line — 2.8% higher — with what we saw in the second half of 2021. Looking...more

Revisions to the DOJ’s Corporate Criminal Enforcement Policy Will Require Companies To Reevaluate Their Compliance Systems

In a recently published memorandum, Deputy Attorney General (DAG) Lisa Monaco announced important updates to the U.S. Department of Justice’s (DOJ’s) approach to investigating and prosecuting corporate crimes. In the...more

Inside the Courts – An Update From Skadden Securities Litigators - September 2022

Derivative Litigation Eighth Circuit Affirms Dismissal of Derivative Securities Action - Carpenters’ Pension Fund of Ill. v. Neidorff, No. 20-3216 (8th Cir. 2022) - Following Centene Corporation’s merger with Health Net,...more

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