Blumenthal
HARTFORD, Conn. (Legal Newsline) - Connecticut Attorney General Richard Blumenthal on Thursday said Connecticut is part of a $422.5 million multi-state settlement with a pharmaceutical corporation that allegedly engaged in off label drug marketing and kickback schemes.
Blumenthal announced the settlement in coordination with Chief State's Attorney Kevin T. Kane and Department of Social Services Commissioner Michael P. Starkowski.
Novartis Pharmaceuticals Corporation allegedly induced physicians to prescribe several drugs in a nationwide off-label drug marketing and kickback scheme.
The lawsuit alleged that from Jan. 1, 2001 through June 30, 2005, Novartis promoted Trileptal for uses that the Food and Drug Administration didn't approve. Although the drug was approved by the FDA to treat partial seizures in patients who have epilepsy, the company also said it could be used in the treatment of bipolar disorder and neuropathic pain.
During that same time period, the company allegedly provided illegal compensation in the form of payments for speaker programs and advisory boards and provided gifts to health care professionals encourage them to help promote and prescribe the drugs Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.
Novartis allegedly also offered and paid illegal reimbursements to health care professionals to promote and prescribe Trileptal.
"This off-label marketing, which my office has vigorously pursued in coordination with other law enforcement agencies, endangers patients for the sake of money," Blumenthal said. "My office will continue to aggressively pursue drug companies that illegally market drugs for unapproved uses."
Novartis will pay the states involved and the federal government a total of $237.5 million in damages and penalties for losses to Medicaid and other federal health care programs. The company will also pay $185 million to resolve criminal allegations.
"This agreement reimburses Connecticut taxpayers for schemes that put self-gain before safety - the illegal promotion of Trileptal for unapproved uses," Blumenthal said. "Novartis promoted its drug and paid off doctors through trips and other compensation‹in an effort to boost prescriptions for Trileptal beyond its limited FDA-approved use."
Under terms of the settlement, the Connecticut Medicaid program will recover $1.8 million.
"This action underscores the need for constant vigilance over public dollars in the Medicaid program," Starkowski said. "The state's pharmaceutical assistance expenditures are about $450 million each year, and the recovery expected from this settlement will help relieve pressure on the overall budget."
The settlement also requires Novartis to enter into a corporate integrity agreement with the Office of the Inspector General of the U.S. Department of Health and Human Services.