About the Author
Paula Ramer is counsel in Kaye Scholer’s White Collar Litigation & Internal Investigations Practice in New York. Her practice includes representing pharmaceutical and medical device companies in government investigations involving allegations of healthcare fraud. She can be reached at firstname.lastname@example.org.
Since Caronia was decided, the government has not been dissuaded from pursuing off-label cases in either the civil or criminal contexts and views its holding as limited.
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