The executive order shifts policy on enforcement of criminal regulatory offenses, steering away from criminal enforcement of strict liability offenses in regulatory matters....more
6/10/2025
/ Controlled Substances Act ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Executive Orders ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Non-Enforcement ,
Regulatory Requirements ,
Strict Liability ,
Trump Administration
In a memorandum dated May 19, 2025, Deputy Attorney General Todd Blanche announced the establishment of a new Civil Rights Fraud Initiative (the Initiative) at the Department of Justice (DOJ)....more
5/28/2025
/ Colleges ,
Department of Justice (DOJ) ,
Diversity and Inclusion Standards (D&I) ,
Educational Institutions ,
Enforcement Actions ,
Enforcement Authority ,
Enforcement Priorities ,
Executive Orders ,
False Claims Act (FCA) ,
Policy Memorandums ,
Risk Management ,
Universities ,
Whistleblowers
Justice Kavanaugh issued a concurring opinion in Wisconsin Bell, which Justice Thomas joined, to question again whether the False Claims Act qui tam provision violates Article II of the US Constitution....more
Navigating the Trump administration executive order impacting pediatric gender dysphoria evidence, coverage, disclosures, regulation, legislation, and enforcement as well as grants to certain medical institutions, including...more
Navigating the Trump administration executive order impacting pediatric gender dysphoria evidence, coverage, disclosures, regulation, legislation, and enforcement as well as grants to certain medical institutions, including...more
Welcome to the latest edition of our Healthcare & Life Sciences Market Update, in which we explore the evolving landscape of investment trends, regulatory challenges, and strategic opportunities shaping the global market....more
The Zafirov decision finds that the False Claims Act qui tam provision violates Article II of the US Constitution.
On September 30, 2024, in United States ex rel. Zafirov v. Florida Medical Associates LLC, Judge Kathryn...more
Companies should prepare for increased regulatory scrutiny into healthcare transactions and increased emphasis on compliance programs.
The Federal Trade Commission (FTC), the Department of Justice (DOJ), and the...more
The Court unanimously held that a defendant’s subjective belief is relevant to scienter under the False Claims Act, even when a defendant’s conduct is consistent with an objectively reasonable interpretation of the law....more
The US regulators have been particularly focused on new players in the health tech space and the novel regulatory issues their products present within the existing legal framework. While the market is ripe with opportunity...more
The Seventh Circuit has created a third standard for evaluating motions to dismiss pursuant to the government’s FCA dismissal authority.
The US Court of Appeals for the Seventh Circuit’s August 17, 2020, opinion in United...more
The Order requires many businesses to close, but allows essential industries to continue operating, and permits employees to work remotely, as applicable.
On March 20, 2020, Illinois Governor J.B. Pritzker issued Executive...more
Leaked DOJ memo instructs government attorneys to consider dismissing certain False Claims Act qui tam actions.
On January 10, 2018, Michael D. Granston, Director of the Commercial Litigation Branch of the Department of...more
The revised FCPA Corporate Enforcement Policy signals DOJ’s emphasis on corporate voluntary self-disclosure, rewarding cooperating companies with a presumption in favor of declination and reductions in penalties.
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