Court Manufacturing Mens Rea 
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.
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.
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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.
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.
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
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