U.S. Army Staff Sgt. Aubree Rundle shot this photograph (available at the DoD online photo archive) in February 2010 of Army Capt. Bryan Johnson and Staff Sgt. Dean Bostick checking the vital signs of a wounded Afghan national army soldier on board a Chinook helicopter at Kandahar Airfield in Afghanistan.

$25 Million Settlement Involves Drug Marketed to Army

Novo Nordisk Inc., a Danish drug maker, agreed to pay that amount to resolve its civil liability for illegally promoting a hemophilia drug for treating traumatic bleeding of combat casualties.

The Justice Department on Friday announced it had reached a $25 million settlement with Novo Nordisk Inc., a drug maker based in Denmark. The settlement resolves its civil liability for promoting NovoSeven, a drug approved by FDA for treating bleeding disorders in hemophiliacs, as a treatment for traumatic bleeding of Army combat casualties. But Justice did not disclose that the drug was marketed to and used by the U.S. Army to treat wounded personnel in Iraq and Afghanistan, and that one of two whistleblowers who filed qui tam lawsuits and will share $3.5 million of the settlement, is an Army doctor, Ian Black, who blew the whistle because he and colleagues saw side effects that worried them. These details come from a Baltimore Sun article written by Robert Little that follows coverage by that newspaper since 2006.

Some wounded soldiers treated with NovoSeven – the Army called it Factor VII -- later died because of blood clots, Little reported.

The Justice news release says Novo Nordisk, which denies wrongdoing, "promoted NovoSeven to health care professionals for off-label uses, including as a coagulatory agent for trauma patients, general surgery, cardiac surgery, liver surgery, liver transplants and intra-cerebral hemorrhage. As a result of this unlawful promotion, Novo Nordisk caused false claims to be submitted to government health care programs that were not reimbursable by those programs. Medicare and Medicaid paid for off-label prescriptions throughout the United States as a result of Novo's focused campaign to influence doctors and hospitals." The federal share of the settlement is $21,425,790.59, and the state Medicaid share is $3,574,209.41, the release states.

The company posted this on its website June 10: "Novo Nordisk announced today that it has reached an agreement with the US Department of Justice and two individuals to settle an investigation and civil lawsuit related to alleged improper marketing practices in the United States regarding NovoSeven®. The company disclosed this investigation on 2 February 2010 in the company's 2009 financial statement. Under the agreement, Novo Nordisk will pay USD 25 million to the settling parties."

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