Violation Tracker Individual Record

Company: 
Spectranetics Corporation
Current Parent Company: 
Royal Philips
Penalty: 
$5,000,000
Year: 
2009
Date: 
December 29, 2009
Offense Group: 
healthcare-related offenses
Primary Offense: 
off-label or unapproved promotion of medical products
Secondary Offense: 
drug or medical equipment safety violation
Violation Description: 

Spectranetics Corporation, a medical device manufacturer, agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company arising from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Justice Department Civil Division
Civil or Criminal Case: 
civil
HQ Country of Parent: 
Netherlands
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
diversified
Specific Industry of Parent: 
diversified
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.