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.

Statute 98

Statute Mens Rea Manufacturing Court 98

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.

Mens Rea 82

Mens Rea Statute Healthcare Manufacturing 82

The IP Law Blog

MARCH 2, 2021

Supreme Court issued numerous landmark decisions in 2020, among those—for trademark scholars and practitioners— Romag Fasteners, Inc. The Court noted that the statute immediately “spells trouble for Fossil and the circuit precedent on which it relies.” 7 While the statute makes willfulness a prerequisite to a pro?ts at 1494-95.

Manufacturing 52

Manufacturing Mens Rea Contract Tort 52

LexForti

NOVEMBER 17, 2022

Before establishment of this statute, there was the absence of any special law which could be entirely designated for the offenses perpetrated against minors. Because of this, the necessity of maintaining the gender neutrality of the statute arose since several young males are also subjected to crimes of sexual nature.

Statute 52

Statute Mens Rea Court Legal 52