Violation Tracker Individual Record

Company: 
Aegerion Pharmaceuticals Inc.
Current Parent Company: 
Amryt Pharma
Penalty: 
$35,000,000
Year: 
2017
Date: 
September 22, 2017
Offense Group: 
safety-related offenses
Primary Offense: 
drug or medical equipment safety violation
Secondary Offense: 
False Claims Act and related
Violation Description: 

Aegerion Pharmaceuticals Inc., a Cambridge, Massachusetts-based subsidiary of Novelion Therapeutics Inc., agreed to plead guilty to charges that that its prescription drug Juxtapid was misbranded because, among other things, Aegerion failed to comply with a Risk Evaluation and Mitigation Strategy (REMS). The resolution also included a deferred prosecution agreement relating to criminal liability under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). In addition, Aegerion agreed to settle allegations that it caused false claims to be submitted to federal health care programs for Juxtapid.? Aegerion agreed to pay more than $35 million to resolve criminal and civil liability arising from these matters.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Justice Department Civil Division
Civil or Criminal Case: 
civil and criminal
Prosecution Agreement: 
deferred prosecution agreement
HQ Country of Parent: 
United Kingdom
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.