Novo Nordisk will pay a $25 million settlement stemming from charges relating to alleged off-label marketing of hemophilia drugs to military and civilian physicians. The promotion of NovoSeven for unapproved uses exposed patients to deadly side effects and defrauded the federal government of millions of dollars.

The whistleblowers behind the 2008 complaint are former Army physician Ian Black and former Novo Nordisk medical science liaison Oscar Montiel. Together, they detailed the company’s alleged efforts to promote the expensive hemophilia drug ($2,000 – $10,000 per vial) for nonhemophiliac patients. The whistleblowers charge that by providing kickbacks for doctors and ignoring studies showing a rise in strokes and heart attacks among NovoSeven patients, the company increased its annual NovoSeven usage from 125 cases in 2000 to 17,813 in 2008.

Since Medicare, Medicaid, TRICARE and the Department of Veterans Affairs generally don’t pay for off-label drug use, the company’s actions led to fraudulent reimbursements and false claims. Dr. Black reported that he initially attempted to voice concerns with the growing use of NovoSeven, and was repeatedly offered kickbacks in return for continued support. Dr. Black and Oscar Montiel will receive 16.7 percent of the recovery.

Read the entire article, “DOJ Intervenes, Settles Whistleblower Case Involving Off-Label Marketing to Military Physicians”