PIERRE, S.D.- Attorney General Marty Jackley announced today that South Dakota has joined with other states and the federal government to reach an agreement in principle with Novartis Pharmaceuticals Corporation (Novartis) to settle allegations it improperly promoted Trileptal and engaged in unlawful kickback schemes to induce physicians to prescribe Trileptal, Diovan, Zelnorm, Sandostatin, Exforge and Tekturna. As a result, Novartis will pay the states and the federal government $237.5 million in damages and penalties for losses to the Medicaid and other federal health care programs. South Dakota’s share of the settlement is $434,079.27.
Additionally, the Office of the United States Attorney for the Eastern District of Pennsylvania filed a one count Information against Novartis Pharmaceuticals Corporation in the United States District Court alleging a misdemeanor violation of the Food, Drug and Cosmetic Act. In a plea agreement with the United States, Novartis has agreed to plead guilty and pay $185 million to resolve the criminal case. Novartis is a pharmaceutical manufacturer incorporated in Delawareand headquartered in East Hanover, New Jersey
Trileptal is an anti-epileptic drug approved by the Food and Drug Administration (FDA) for the treatment of partial seizures in patients who have epilepsy. The civil settlement resolves claims from January 1, 2001 through June 30, 2005, that Novartis promoted the sale and use of Trileptal for certain uses not approved by the FDA. The settlement resolves a government investigation into promotional activities by Novartis, which were directed at psychiatrists and other health care professionals, to induce physicians to prescribe Trileptal for unapproved uses such as the treatment of bipolar disorder and neuropathic pain. Novartis also offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Trileptal.
The settlement also resolves allegations that from January 1, 2002 to December 31, 2009, Novartis provided illegal remuneration, through mechanisms such as payments for speaker programs, advisory boards and the giving of gifts, (including entertainment, travel and meals), to health care professionals to induce them to promote and prescribe the drugs Diovan, Zelnorm, Sandostatin, Exforge, and Tekturna.
As one of the conditions of the settlement, Novartis will enter into a Corporate Integrity Agreement with the Office of the Inspector General of the United States Department of Health and Human Services (“HHS-OIG”), which will closely monitor Novartis’ practices going forward.
FOR IMMEDIATE RELEASE: Thursday, September 30, 2010
CONTACT: Paige Wilbur, (605) 773-3215