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.

Mens Rea 83

Mens Rea Statute Healthcare Manufacturing 83

FDA Law Blog

AUGUST 4, 2022

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. Similarly, the Court drew on the plain meaning of “willfully” to reject Pfizer’s argument that the term suggests “an element of corruption.”

Statute 98

Statute Mens Rea Manufacturing Court 98

The Crime Report

JANUARY 6, 2022

In a forthcoming (May 2022) book, Criminology on Trump, I have marshalled the mens rea type of evidence that I hope prosecutors and the Department of Justice will consider in charging Trump and his associates with a variety of white-collar crimes. Several weeks after losing the 2020 election, on Jan.6, Gregg Barak.

Mens Rea 140

Mens Rea Real Estate Felony Laws 140