(Mealey's) Danish drug and biologics maker Novo Nordisk will pay a total of $26.7 million to settle separate False Claims Act lawsuits that include allegations that it paid military doctors to use a hemophilia drug off-label on wounded soldiers and paid retail pharmacists for the names of diabetic patients who bought insulin, the federal government and company announced June 10 (United States of America, ex rel. Ian Black, et al. v. Novo Nordisk Inc., et al., No. 1:08-cv-2900, D. Md., and United States of America, ex rel. Pepper v. Novo Nordisk, et al., No. 05-cv-3505, E.D. N.Y.).
In 2008, Ian Black, a former active-duty U.S. Army physician, and Oscar Montier, a former Novo Nordisk medical science liaison, filed a False Claims Act lawsuit on behalf of the federal government and several states in the U.S. District Court for the District of Maryland. They alleged that Novo Nordisk promoted its hemophilia drug NovoSeven for off-label use among military and civilian doctors by paying grants, speaker fees and kickbacks.
Under a settlement agreement for that lawsuit, Novo Nordisk will pay the federal government $21,425,790 and state Medicaid programs $3,574,209 plus 3 percent interest from March 1, 2001. Relators Black and Montier will be paid 16.7 percent of the federal settlement, or $3,578,106.
In 2005, a relator whose full name remains under seal filed a False Claims Act lawsuit on behalf of the federal government and several states in the U.S. District Court for the Eastern District of New York. According to the U.S. attorney for the Eastern District, Novo Nordisk sales representatives in four states paid Rite Aid pharmacists for the names of diabetic patients so they could pitch the company's Novolin and Novolog insulins to the patients and their doctors.
Under that settlement agreement, Novo Nordisk will pay the federal government $897,000 and the state Medicaid programs $828,000, plus 3 percent interest from March 11, 2001. The unidentified relator does not object to the settlement and retains the right to seek proceeds from the settlement.
Novo Nordisk also entered into a five-year corporate integrity agreement with the Office of Inspector General for the U.S. Department of Health and Human Services.
Novo Nordisk denies any wrongdoing and said it settled to "avoid the distraction and costs of a lengthy legal battle." The company said it does not promote off-label uses of its products.
[Editor's Note: Full coverage will be in the June 16 issue of Mealey's Emerging Drugs & Devices. In the meantime, the settlement agreements are available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. NovoSeven settlement agreement. Document #28-110616-007P. Novolin/Novolog settlement agreement. Document #28-110616-008P. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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