FDA Law Blog

JUNE 28, 2022

Supreme Court (six justices) issued a noteworthy opinion on criminal liability related to prescribers of controlled substances. 1) to manufacture, distribute, or dispense, or possess with intent to manufacture, distribute, or dispense, a controlled substance; or. (2) Gilbert & Karla L. United States, No. 20-1410 and Kahn v.

Mens Rea 98

Mens Rea Court Manufacturing Government 98

FDA Law Blog

NOVEMBER 6, 2022

Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. The Second Circuit’s Interpretation of the AKS and its Mens Rea Element. Background.

Mens Rea 83

Mens Rea Statute Healthcare Manufacturing 83

FDA Law Blog

AUGUST 4, 2022

Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. That court granted summary judgment to the government on the APA claim and rejected Pfizer’s narrower reading of the AKS, which would require an element of “corrupt” intent to impose AKS liability.

Statute 98

Statute Mens Rea Manufacturing Court 98

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. es the threat posed to companies that rely on third-party manufacturers. Summary of the Supreme Court’s Opinions. Fossil, Inc. Practitioners should expect that juries will ? Romag solidi?es

Manufacturing 52

Manufacturing Mens Rea Contract Tort 52

SCOTUSBlog

FEBRUARY 28, 2022

Share In the midst of a national opioid crisis that claimed more than 100,000 lives in this country over the past year, the Supreme Court will hear a case on Tuesday about the relevance of doctors’ subjective intentions in criminal prosecutions for unlawful distribution of controlled substances. While on the surface, the case, Ruan v.

Mens Rea 87

Mens Rea Court Government Manufacturing 87