On May 7, 2019, the Department of Justice (DOJ) released guidance for civil prosecutors in determining how to assess cooperation in False Claims Act (FCA) cases. See DOJ’s press release and its revised manual. In particular,...more
If one appellant has its way, the False Claims Act (FCA) would be gutted by way of its qui tam provisions struck down as unconstitutional by the United States Supreme Court. That is the position taken by Intermountain Health...more
5/15/2019
/ Appeals ,
Appointments Clause ,
Article III ,
Constitutional Challenges ,
False Claims Act (FCA) ,
Federal Rules of Civil Procedure ,
Hospitals ,
Petition for Writ of Certiorari ,
Physician Medicare Reimbursements ,
Physicians ,
Qui Tam ,
Relators ,
Reversal
Most busy scientific research laboratories have a spectrum of projects underway at any given time. Some projects are producing exciting results, and others seem to be heading nowhere. Why not shift personnel from the losers...more
On May 9, 2018, the U.S. Department of Justice (DOJ) announced a policy related to resolutions of criminal and civil corporate enforcement. The new “Policy on Coordination of Corporate Resolution Penalties” was issued by...more
For years, misconduct in scientific research was policed primarily by the Office of Research Integrity (ORI) at the U.S. Department of Health and Human Services. After a lengthy and confidential review, an institution...more
On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney...more
3/6/2018
/ Anti-Kickback Statute ,
Attorney General ,
CGMP ,
Department of Justice (DOJ) ,
Enforcement Guidance ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Misleading Statements ,
Off-Label Promotion ,
Opioid ,
Pharmaceutical Industry ,
REMS
In a January 10, 2018 memo that leaked last week (the “Granston Memo”), the U.S. Department of Justice (“DOJ”) directs its prosecutors to more seriously consider dismissing meritless False Claims Act (“FCA”) cases brought by...more