Columbus -- Ohio Attorney General Mike DeWine announced today that Ohio has joined other states and the federal government to reach an agreement in principle with pharmaceutical manufacturer, UCB, Inc., to settle allegations that the company marketed the anti-epileptic drug Keppra® for off-label purposes and caused the Ohio Medicaid program to pay false reimbursement claims.
Ohio will receive $1,322,237.20 in state and federal funds under the agreement.
"This is just the latest example of our ongoing effort to ensure that Medicaid dollars are used properly," said Attorney General DeWine.
Medicaid programs nationwide will receive approximately $21,049,621 of the total settlement. Medicaid is funded jointly by the federal and state governments.
Keppra® was approved by the Food and Drug Administration for several indications related to epilepsy. The government's investigation revealed that from Jan. 1, 2003, through March 31, 2005, UCB promoted the sale and use of Keppra® for headaches, migraines, pain, bipolar disorder, mood disorders, and anxiety, all of which were uses not approved by the FDA. Further, some of the uses were not medically accepted indications. The unapproved uses of Keppra® were not eligible for reimbursement by state Medicaid programs.
The UCB settlement involved both criminal and civil components. Under the agreement, UCB pled guilty in federal court to one misdemeanor count of "misbranding" violation of the federal Food, Drug and Cosmetic Act. As part of the criminal plea, UCB agreed to pay a fine and costs totaling $8,631,152. In addition, to resolve civil allegations, UCB agreed to pay the federal government and participating state Medicaid programs $25,764,530, plus interest.
The investigation was initiated by lawsuits filed in the United States District Court for the District of Columbia and the District of Oregon under the qui tam provisions of the Federal False Claims Act and similar state false claims statutes.
"This is also a reminder that a False Claims Act in Ohio would mean the state could retain a greater share of such recoveries," said Attorney General DeWine.
A team representing the National Association of Medicaid Fraud Control Units participated in the investigation and conducted settlement negotiations with UCB on behalf of the states. Team members included representatives from Colorado, Florida, Georgia, Michigan, Nebraska, New York, North Carolina, Texas and Virginia.
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