Violation Tracker Individual Record

Company: 
Healthpoint Ltd. and DFB Pharmaceuticals
Penalty: 
$28,000,000
Year: 
2012
Date: 
December 6, 2012
Offense Group: 
healthcare-related offenses
Primary Offense: 
off-label or unapproved promotion of medical products
Secondary Offense: 
kickbacks and bribery
Violation Description: 

Healthpoint Ltd. and DFB Pharmaceuticals agreed to pay up to $48 million to resolve allegations that Healthpoint caused false claims to be submitted to Medicare and Medicaid for an unapproved drug, Xenaderm, which was ineligible for reimbursement by those programs. Under the terms of the agreement, Healthpoint and DFB agreed to pay $28 million, plus another $20 million if there is a change in ownership of Healthpoint or DFB over the next three years.

Level of Government: 
federal
Action Type: 
agency action
Agency: 
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
civil
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.