Office of the Attorney General
Attorney General Conway Announces Settlement with Pharmaceutical Manufacturer Forest Laboratories
Attorney General Jack Conway and his Office of Medicaid Fraud and Abuse Control today announced that Kentucky will participate in a settlement with generic pharmaceutical manufacturer Forest Laboratories, Inc. over false and misleading information about the safety of antidepressant drugs Celexa and Lexapro and Levothroid, a drug used for treatment of hypothyroidism.
Under the terms of the settlement, Forest has agreed to pay a total of $313 million to resolve civil and criminal claims. The federal government, Kentucky and other participating states contend that Forest caused false claims to be submitted to the Medicaid program by illegally disseminating false and misleading information to physicians about the safety and efficacy of Celexa and Lexapro for use in treating pediatric patients, when those uses had not been approved by the Food and Drug Administration. Forest also paid illegal kickbacks to physicians to induce them to prescribe Celexa and Lexapro.
Additionally, Forest distributed the drug Levothroid after it had been advised by the FDA that Levothroid did not qualify for coverage by the Medicaid program. In fact, Forest increased the distribution of the unapproved Levothroid, after the FDA's announcement and failed to advise the federal Center for Medicare and Medicaid Services that the unapproved Levothroid no longer qualified as a covered outpatient drug.
Forest was also required to execute a Corporate Integrity Agreement with the United States Department for Health and Human Services to insure that these illegal marketing activities do not occur again. One of the terms of the Corporate Integrity Agreement requires Forest to send doctors a letter notifying them about the settlement.
"I am pleased that we have reached this agreement with Forest and that it includes a provision that will prevent the company from engaging in these illegal marketing activities in the future," General Conway said. "Drug companies that engage in the off-label marketing of their products are a burden to taxpayers and jeopardize the health and safety of consumers."
As a result of the settlement, the Kentucky Medicaid program will receive $3,173,978 that represents double the amount that Kentucky Medicaid expended for prescriptions written as a result of the company's off- label marketing. After reimbursing the federal government for its contribution, the Kentucky Medicaid program will retain $946,214 of the settlement proceeds. Forest has also agreed to plead guilty to one felony count of obstructing justice, one misdemeanor count of distributing an unapproved drug in interstate commerce and one misdemeanor count of distributing a misbranded drug in interstate commerce.
Attorney General Conway recently announced settlements with Schwarz Pharma, Novartis Pharmaceuticals Corp. and Allergan USA to resolve allegations of improper and illegal marketing of their products. As a result of those settlements, Kentucky's Medicaid program will receive nearly $4.7 million.
Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $141 million for the state and federal Medicaid programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.
The Attorney General's Tip Line for reporting allegations of Medicaid fraud is 1-877-228-7384.