As the result of the filing of two False Claims Act lawsuits, Pennsylvania-based Shire Pharmaceuticals LLC (“Shire”) has agreed to pay $56.5 million to resolve allegations regarding its marketing and promotion of Adderall XR, Vyvanse, Daytrana, Pentasa and Lialda, according to a DoJ press release.  A former Shire executive, Dr. Gerardo Torres, and three former Shire sales representatives, Anita Hsieh, Kara Harris and Ian Clark, filed the lawsuits under the qui tam provisions of the False Claims Act.  The settlement resolves allegations that between January 2004 and September 2010, Shire and its employees or representatives misrepresented and promoted various drugs including Adderrall XR, Vyvanse, Daytrana, Pentasa and Lialda despite lacking the clinical data to support its claims.

“Marketing efforts that influence a doctor’s independent judgment can undermine the doctor-patient relationship and short-change the patient.” said U.S. Attorney Zane David Memeger for the Eastern District of Pennsylvania.  “Where children’s medication is concerned, it can interfere with a parent’s right to clear information regarding the risks to the safety and health of their child.  Shire cooperated throughout this investigation and, in advance of this settlement, began to correct its marketing activities.”

To report False Claims Act violations, please contact Frohsin & Barger.