Violation Tracker Individual Record

Company: 
Elan Corporation PLC
Current Parent Company: 
Perrigo
Penalty: 
$203,000,000
Year: 
2010
Date: 
December 15, 2010
Offense Group: 
healthcare-related offenses
Primary Offense: 
off-label or unapproved promotion of medical products
Violation Description: 

Irish pharmaceutical manufacturer Elan Corporation PLC and its U.S. subsidiary Elan Pharmaceuticals Inc. agreed to pay more than $203 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Zonegran. In a separate civil settlement, Japanese drug marketer Eisai Inc., which purchased the drug from Elan, will pay $11 million to resolve civil liability for off-label marketing of Zonegran.

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
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.