Violation Tracker Individual Record

Company: 
Scios Inc.
Current Parent Company: 
Johnson & Johnson
Penalty: 
$85,000,000
Year: 
2011
Date: 
October 5, 2011
Offense Group: 
healthcare-related offenses
Primary Offense: 
off-label or unapproved promotion of medical products
Violation Description: 

Scios Inc., a subsidiary of pharmaceutical giant Johnson & Johnson, pleaded guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act for introducing into interstate commerce its heart failure drug, Natrecor, for a use that was not approved by the Food and Drug Administration, the Justice Department announced. The district court also sentenced Scios, based in Fremont, Calif., to pay an $85 million criminal fine in accordance with the plea agreement between Scios and the United States.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
criminal
HQ Country of Parent: 
USA
HQ State of Parent: 
New Jersey
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.