U.S. Department of Justice – White-Collar Criminal Law

August 22, 2022 by Duane Morris

Fraud-On-The-FDA Theory Of Liability Reawakened by DOJ Filing

On June 3, the U.S. Department of Justice Civil Division’s Washington, D.C., office filed a statement of interest in a relator’s action, arguing that “[c]onduct giving rise to a regulatory violation can also give rise to” False Claims Act liability.

The case is U.S. ex rel. Patricia Crocano v. Trividia Health Inc., before the U.S. District Court for the Southern District of Florida.

Specifically, the DOJ requested “that the ruling not foreclose the possibility that, under certain circumstances,” conduct that violates the Federal Food, Drug and Cosmetic Act or U.S. Food and Drug Administration regulations “could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,”[3] colloquially known as “fraud on the FDA.”

This filing makes clear the DOJ’s decision to reawaken a theory of liability thought to be dead.

To read the full text of this article by Duane Morris attorneys Eric Breslin, Frederick R. Ball and Brittany Pagnotta, originally published in Law360, please visit the firm website.

June 28, 2022 by Duane Morris

Fraud-on-the-FDA Theory of False Claims Act Liability Clarified by DOJ

On June 3, 2022, the Civil Division of the Department of Justice filed a statement of interest in a relator’s action in the Southern District of Florida, arguing that “[c]onduct giving rise to a regulatory violations can also give rise to [False Claims Act] liability.” Specifically, requesting “that the ruling not foreclose the possibility that, under certain circumstances, conduct giving rise to violations of the [Federal Food, Drug and Cosmetic Act] or FDA regulations could be material to the government’s payment decisions and provide a basis for FCA liability assuming all necessary FCA elements are demonstrated,” also known as “fraud on the FDA.”

To read the full text of this Alert, please visit the firm website.

December 13, 2021December 13, 2021 by Frederick R. Ball

DOJ Reinstates and Augments Prior Corporate Criminal Enforcement Policies: Now Requiring Disclosure of ALL Involved Individuals and Consideration of ALL Prior Corporate Misconduct

On October 28, 2021, Deputy United States Attorney General Lisa Monaco issued a memorandum marking the first major announcement on corporate criminal enforcement from the Department of Justice (“DOJ”) under the Biden Administration (“Monaco Memo”). Most notably, this memorandum: (1) reinstates the Individual Accountability Policy originally announced in the Yates Memo and (2) guides prosecutors to look at all prior misconduct, not just those instances similar to the misconduct at issue in the present investigation. Continue reading “DOJ Reinstates and Augments Prior Corporate Criminal Enforcement Policies: Now Requiring Disclosure of ALL Involved Individuals and Consideration of ALL Prior Corporate Misconduct”

September 1, 2021 by Duane Morris

Prosecution for Noncompliance with Agency Guidance Documents Allowed by Attorney General’s Memorandum

On July 1, 2021, U.S. Attorney General Merrick Garland published a memorandum that rescinds two previous memoranda―the Sessions Memorandum and Brand Memorandum―that prohibited Department of Justice attorneys from using noncompliance with federal agency guidance documents as a basis for civil and criminal enforcement cases. Garland’s memorandum states these previous policies were “overly restrictive,” “discouraged the development of valuable guidance” and hindered DOJ’s litigation of cases when relevant agency guidance was available.

To read the full text of this Duane Morris Alert, please visit the firm website.

May 6, 2021 by Duane Morris

Expect Increasing Scrutiny of Wage-Fixing, No-Poach Deals

Companies have long sought to prevent their competitors — particularly in skilled fields like life sciences, health care, software development and engineering — from benefiting from the talents and training of their employees.

Examples of such efforts include noncompete agreements between employers and employees, and carefully worded joint venture agreements that prohibit one partner from insourcing the know-how of another partner.

Although noncompete agreements between employers and employees have been subject to scrutiny for years, agreements between employers to restrict solicitation of each other’s employees or to fix employee wages have largely flown under the radar.

In fact, it was not until a little over four years ago that federal antitrust enforcers signaled that such agreements could be presumed illegal and criminally prosecuted. And even that policy change, significant though it was, did not bring an immediate uptick in enforcement activity.

That wait now appears to be over. The U.S. Department of Justice’s Antitrust Division has recently been aggressively bringing enforcement actions against labor market collusion, with more cases on the horizon.

To read the full text of this article (originally published in Law360) by Duane Morris partners Christopher Casey, Sean McConnell and Brian Pandya, please visit the firm website.

March 24, 2020 by Duane Morris

U.S. Department of Justice Files Civil Complaint for COVID-19-Related Fraud

By Brett M. Feldman and Jessica Linse

Since the outbreak of the COVID-19 virus, law enforcement officials throughout the country have publicly committed to aggressively combatting pandemic-related fraud. Those pronouncements have translated into action focused, at least at this early stage, upon frauds which might impact consumers’ health and safety. The first federal civil enforcement action took place on Saturday, March 21, 2020. On that date, the U.S. Department of Justice, in coordination with the U.S. Attorney for the Western District of Texas, filed the first civil enforcement action against a COVID-19 related fraud. Prosecutors sought an injunction shutting down a website, which purportedly offered to provide “free” coronavirus “vaccine kits” for a $4.95 shipping and handling fee. This request for injunctive relief, which resulted in a temporary restraining order pursuant to 18 U.S.C. § 1345, is likely an omen of more to come. Continue reading “U.S. Department of Justice Files Civil Complaint for COVID-19-Related Fraud”