Government Laws Mens Rea Statute 
FDA Law Blog
AUGUST 4, 2022
Kirschenbaum — In a recent decision, the Second Circuit upheld the HHS Office of the Inspector General (OIG)’s position that Pfizer’s proposed copay assistance program for its high-cost heart treatment would violate the Federal Anti-Kickback Statute (AKS). The Second Circuit’s Interpretation of the Anti-Kickback Statute. Pfizer, Inc.
SCOTUSBlog
JUNE 28, 2022
Even in the midst of a historic opioid crisis, and an intensely fractured Supreme Court term, the justices found common ground in longstanding presumptions of criminal law and the core principle of physician discretion. Breyer’s majority opinion reaches essentially the same result, but puts a much higher burden on the government.
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JURIST
APRIL 15, 2024
Gijs de Bra is a JURIST Assistant Editor and SCOTUS special correspondent, and a 2L at Cornell Law School. When, if ever, does a person “corruptly” solicit or offer a gift with intent to influence government action? The party briefs mostly focused on the word “rewarded” in the statute.
SCOTUSBlog
JUNE 24, 2021
pleaded guilty to violating a federal law barring people convicted of a felony from possessing a firearm. At sentencing, the government sought an enhancement under the ACCA; it claimed that three of Borden’s prior felony convictions were violent felonies. The district court ruled for the government and the U.S. Borden objected.
FDA Law Blog
NOVEMBER 6, 2022
Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element.
SCOTUSBlog
MARCH 2, 2022
The government argues the intent standard is an objective one — an “honest effort” to comply with professional norms. The government’s burden of proof also was the subject of much back and forth, even though it was not a major component of the briefing. Lawrence Robbins argues on behalf of petitioner Xiulu Ruan.
The IP Law Blog
MARCH 2, 2021
At the Supreme Court, Romag argued that requiring willfulness for a profits award “flouts the plain text of section 35(a) and undermines the broader policies of the Lanham Act,” and is a “serious misinterpretation of federal law” that should not be allowed to stand. 7 While the statute makes willfulness a prerequisite to a pro?ts
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