Tag Archives: Department of Justice

Government rewards biopharma by declining penalty

In a settlement this week, the government rewards prompt action of a biopharma company by declining a penalty. Although an enforcement action by the Securities and Exchange Commission, the approach corresponds to a recent announcement by the Department of Justice. Companies that self-report, cooperate, and remediate will receive lenient treatment. This settlement makes clear just how valuable those efforts can … Continue Reading

Judge Rejects Healthcare Company’s “C” Plea

A federal judge rejects healthcare company’s “C” plea as not good enough.  Lessons from this decision apply to any healthcare provider trying to negotiate a specific sentence with the federal government. A summary of the judge’s criticism follows a short background about a C plea. Types of Guilty Pleas Federal Criminal Rule 11(c)(1) governs plea agreement procedure. It … Continue Reading

$762 Million Settlement by Amgen of Civil, Criminal, and Kickback Claims Approved by Judge

Yesterday, Amgen received approval of a global settlement from the federal judge in New York presiding over the criminal case filed against Amgen by the Department of Justice regarding the off-label promotion of the anemia drug Aranesp. The settlement resolves criminal charges and civil kickback claims filed by the federal government, claims of Medicaid fraud filed by 49 states … Continue Reading

A Scary Investigation Ends Well

Shortly before Halloween of last year, a Squire Sanders healthcare client received an omen that all was not well – a Civil Investigative Demand (“CID”) served by the United States Department of Justice (DOJ).  Broad, aggressive, and without identifying any pending legal complaint (CIDs usually don’t), the CID made a frighteningly lengthy list of demands … Continue Reading
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