Author Archives: gg3051

Third Circuit Has Opportunity to Rule on Constitutionality of False Claims Act (FCA)

by Joshua Drew, Ian Herbert, Bradley Markano, and Connor Farrell

Left to right: Joshua Drew, Ian Herbert, Bradley Markano, and Connor Farrell (photos courtesy of Miller & Chevalier)

On July 14, 2025, Janssen filed an appeal to the Third Circuit challenging what it characterized in its brief as the “largest ever” judgment under the federal False Claims Act (FCA): approximately $1.6 billion, including over $1.2 billion in civil penalties and $360 million in treble damages. The scope of liability imposed on the healthcare company, along with unique facts underlying the case, present several important constitutional issues, including Article II-based challenges that the FCA’s qui tam provisions improperly delegate to relators the executive authority to pursue punitive quasi-criminal penalties, as well as whether the penalties imposed violate the Fifth Amendment’s Due Process Clause or Eighth Amendment’s Excessive Fines Clause.

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White House’s AI Action Plan: Winning the Race in a Patchwork Regulatory Era

By Joshua Ashley Klayman, Ieuan Jolly, Jeffrey Cohen, and Caitlin Potratz Metcalf

Left to right: Joshua Ashley Klayman, Ieuan Jolly, Jeffrey Cohen, and Caitlin Potratz Metcalf (photos courtesy of Linklaters)

On July 23, 2025, the White House published Winning the AI Race: America’s AI Action Plan (the AI Action Plan), a comprehensive effort aimed to solidify United States leadership in artificial intelligence. The AI Action Plan acknowledges the U.S.’ uniquely complex—and, at times, conflicting—regulatory landscape, including the patchwork of state-level laws that impact innovation, compliance, and policy predictability. The Action Plan calls for national leadership and seeks a unified, pro-innovation regulatory approach, with an understanding that states will continue to develop their own laws. Businesses should prepare for both the opportunities and the compliance challenges that will arise as the Action Plan is implemented.

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Antitrust Insights from the Administration’s First Six Months

by Ilene Knable Gotts, Nelson O. Fitts, Damian G. Didden, Christina C. Ma, and Emily E. Samra

Left to right: Ilene Knable Gotts, Nelson O. Fitts, Damian G. Didden, Christina C. Ma, and Emily E. Samra (photos courtesy of Wachtell, Lipton, Rosen & Katz)

As predicted, antitrust merger enforcement under the second Trump Administration exhibits a return to a more restrained approach at both the Federal Trade Commission and the Antitrust Division of the Department of Justice.  Most refreshingly, the agencies appear committed to good faith engagement with merging parties.  The FTC lifted its four-year “temporary” suspension of early terminations of the HSR waiting period, and a senior Division official recently stated that the DOJ will “not send ‘scarlet’ letters warning parties that they ‘close at their own risk’”—a practice adopted under the prior administration.  In recent orders, the FTC highlighted the importance of Commission staff and merging parties working together in “good faith” during merger reviews.  In public statements, both the FTC and DOJ have eschewed “turning the HSR review into an extortion racket.” These commitments reflect a welcome return to established patterns of antitrust practice, where proactive engagement with regulators can lead to efficient outcomes for lawful transactions.  

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CPPA Adopts Long Awaited Rulemaking Package

by Avi Gesser, Johanna N. Skrzypczyk, HJ Brehmer, and Melyssa Eigen

Left to right: Avi Gesser, Johanna N. Skrzypczyk, HJ Brehmer, and Melyssa Eigen (photos courtesy of Debevoise & Plimpton LLP)

The California Privacy Protection Agency (the “CPPA”) Board met on July 24, 2025, to decide whether to adopt its comprehensive rulemaking package covering cybersecurity audits, automated decision-making technology, and other adjustments to its existing regulations (collectively, the “Draft Regulations”). We have written about these topics in December 2024, February 2025, and May 2025 respectively. Ultimately, after its initial 45-day comment period and additional revisions, the Board decided to finalize the text of the rulemaking package (the “Regulations”).

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DOJ Secures First Criminal Conviction in Wage-Fixing Case

by Christopher A. Miller and Nicole Jefferson

Left to right: Christopher A. Miller and Nicole Jefferson (photos courtesy of Miller Shah LLP)

On April 14, 2025, the Department of Justice (DOJ) Antitrust Division (“The Division”) secured its first wage-fixing criminal conviction in United States v. Lopez, after a federal jury found that Eduardo “Eddie” Lopez violated Section 1 of the Sherman Antitrust Act (“Section 1”) by engaging in wire fraud and wage fixing. This decision signifies a shift in the DOJ’s approach to antitrust conduct in the labor market toward an expansion of criminal enforcement and deviates from the majority of antitrust litigation, which has largely been civilly prosecuted.  

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Whistleblowers Receive New Pathway for Reporting as DOJ Announces Antitrust Whistleblower Reward Program

by Max Rodriguez and Bianca Beam

Left to right: Max Rodriguez and Bianca Beam (photos courtesy of Law Office of Max Rodriguez PLLC)

As discussed in a prior post,[1] last year the Department of Justice announced new pilot programs for whistleblowers in the following U.S. Attorney’s Offices: the Southern District of New York[2]; Eastern District of New York[3]; Northern District of California[4]; Central District of California[5]; District of New Jersey[6]; District of Columbia[7]; Southern District of Texas[8]; Northern District of Illinois[9]; Southern District of Florida[10]; Eastern District of Virginia[11]; and the Western District of Virginia.[12]

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Italy under OECD Scrutiny: Foreign Bribery and the Rule of Law

by Simone Lonati 

Photo courtesy of the author

In order to respond to the phenomenon of the so-called “global crime”[1] in the last decades there has been a proliferation of multilateral international and regional treaties in criminal matters, together with executives and soft law measures in the field. International corruption is not an exception: starting from the 1990s, thanks to the pivotal role of the United States back in 1977 when it adopted the Foreign Corrupt Practices Act, there has been a wave of conventions adopted by bodies such as the OECD, the UN, the Council of Europe and the European Union, each bringing different approaches and demands to domestic legal systems.

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Second Circuit Reinstates FIFA Bribery Convictions, Reviving Honest Services Fraud Prosecutions for Foreign Commercial Bribery

by David A. Last, Rahul Mukhi, Victor L. Hou, Lisa Vicens, Matthew M. Yelovich, and Sarah Pyun

From left to right:  David A. Last, Rahul Mukhi, Victor L. Hou, Lisa Vicens, Matthew M. Yelovich, and Sarah Pyun (photos courtesy of Cleary Gottlieb Steen & Hamilton LLP)

In a significant decision with broad implications for companies and individuals operating internationally, the U.S. Court of Appeals for the Second Circuit has reversed the acquittal of a former media executive and a sports marketing company in the long-running FIFA bribery investigation.[1]  The ruling reinstates jury convictions for honest services wire fraud and money laundering conspiracy, holding that the federal honest services fraud statute, 18 U.S.C. § 1346, can apply to foreign commercial bribery schemes.[2]

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DOJ Civil Division Prioritizes Illegal DEI

by Jennifer Loeb, Austin Evers, Grace Bruce, and Young Park

From left to right: Jennifer Loeb, Austin Evers, Grace Bruce, and Young Park (photos courtesy of Freshfields Bruckhaus Deringer LLP)

Combatting “illegal” Diversity, Equity and Inclusion (DEI) remains a “Day One” priority in Washington. President Trump issued executive orders on DEI on his first day in office. Attorney General Bondi likewise issued her own memos on her first day at the Department of Justice. And now, the new head of the Department of Justice’s Civil Division has followed suit and issued his own memo on his first day, marking DEI-related topics as two of the Division’s top five priorities. This is yet another indicator that the administration appears to be shifting into the enforcement phase of its DEI reset. Health care and life sciences companies have particular reason to take note.

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Maturing Compliance with the Bulk Sensitive Data Rule before the July 8, 2025 Safe Harbor Expires

by Luke Dembosky, Avi Gesser, Erez Liebermann, Rick Sofield, Johanna N. Skrzypczyk, and Mengyi Xu

Top left to right: Luke Dembosky, Avi Gesser, Erez Liebermann, Rick Sofield, Johanna N. Skrzypczyk, and Mengyi Xu (photos courtesy of Debevoise & Plimpton LLP)

All eyes are on the DOJ Bulk Sensitive Data Rule (28 C.F.R. Part 202) and July 8, 2025, when the recently announced good-faith safe harbor expires. The rule, which the Department of Justice now refers to as the Data Security Program (the “DSP”), creates a comprehensive export control regime to restrict the transfer of bulk sensitive personal and government-related data to foreign adversaries deemed threats to U.S. national security. On April 11, 2025, shortly after the first effective date of the DSP, the National Security Division (“NSD”) of DOJ issued a suite of three policy and guidance documents to facilitate compliance with the DSP, including a 90-day civil enforcement safe harbor for good-faith compliance. As previously discussed, the DSP seeks to address the bipartisan concern that sensitive datasets could be exploited by foreign adversaries for espionage, cyberattacks, malign influence, and coercion, which would undermine the United States’ national security interests.

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