Violation Tracker Individual Record

Company: 
Endo Health Solutions Inc.
Current Parent Company: 
Endo International
Penalty: 
$192,700,000
Year: 
2014
Date: 
February 21, 2014
Offense Group: 
healthcare-related offenses
Primary Offense: 
off-label or unapproved promotion of medical products
Violation Description: 

Pharmaceutical company Endo Health Solutions Inc. and its subsidiary Endo Pharmaceuticals Inc. agreed to pay $192.7 million to resolve criminal and civil liability arising from Endo's marketing of the prescription drug Lidoderm for uses not approved as safe and effective by the Food and Drug Administration. The resolution included a deferred prosecution agreement and forfeiture totaling $20.8 million and civil false claims settlements with the federal government and the states and the District of Columbia totaling $171.9 million.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
civil and criminal
Prosecution Agreement: 
deferred prosecution agreement
HQ Country of Parent: 
Ireland (reincorporated for tax reasons)
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
pharmaceuticals
Specific Industry of Parent: 
pharmaceuticals
Source Notes: 
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.