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Federal Contractor Misconduct Database (FCMD)

The federal government routinely awards contracts to companies with histories of misconduct, including contract fraud and other violations. POGO believes that providing this website will help to improve contracting decisions and increase public knowledge of how the government spends billions of taxpayer dollars each year. Read more…

Galmines v. Novartis Pharmaceutical Corp. (Elidel False Claims)

Donald Galmines, a former Novartis marketing representative, filed a False Claims Act lawsuit alleging that Novartis misrepresented and concealed information about the safety, efficacy, and appropriate use of Elidel, a topical skin cream used to treat eczema, and improperly induced health care providers to prescribe Elidel. Galmines alleged that Novartis engaged in a practice known as “off-label marketing” by requiring its sales representatives to induce doctors to prescribe Elidel for uses not approved, and specifically rejected, by the Food and Drug Administration (FDA). The primary off-label use at issue was for treatment of eczema, or “atopic dermatitis,” in children younger than two years of age. In 2005, the FDA required Novartis to put a “Black Box Warning” on Elidel packaging warning that certain cancers in infants were associated with the use of Elidel. In October 2012, Novartis paid $19.9 million to settle with the State of Texas. In October 2016, Novartis agreed to pay $35 million to resolve federal and state false claims allegations.

Misconduct Type
Health
Enforcement Agency
Multiple Agencies
Contracting Party
Health and Human Services
Court Type
Civil
Disposition
Settlement
Date of TX Settlement Announcement
10/30/2012
Contractors Involved Penalty
Total
Novartis AG $54,900,000
Further Information Released
Fed/State Settlement Agreement 7/28/2016
4th Amended Complaint 3/12/2015
Law Firm Press Release 10/30/2012
Texas AG Press Release 10/30/2012
Texas Settlement Agreement 10/22/2012

Federal Contractor Misconduct Database