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Pharmaceutical Company Settles Allegations Regarding Marketing Improprieties for Celexa, Lexapro and Levothroid

 

MADISON — Attorney General J.B. Van Hollen announced today that Forest Laboratories, Inc. and its subsidiary, Forest Pharmaceuticals, Inc., have paid $1,427,527.98 to Wisconsin Medicaid as part of a settlement to resolve allegations of the off-label marketing of Celexa and Lexapro, and filing false claims for Levathroid. That state share and the remainder payable to the federal government are part of a total $3,103,062.36 attributable to the jointly funded state and federal health care program meant to serve Wisconsin's neediest residents.

 

The payments were part of a comprehensive settlement announced by the federal government last September. The Medicaid payments to the states and federal government total approximately $131 million as a component of the civil resolution of these matters for approximately $149 million. It also includes payment for Medicare, Tricare, and the Federal Employee Health Benefits Program.

 

The comprehensive settlement also includes a Corporate Integrity Agreement (CIA) and a criminal component. The criminal resolution required Forest Pharmaceuticals, Inc. (the subsidiary) to plead to one felony count of obstructing justice and two misdemeanor counts of distributing unapproved and misbranded drugs in interstate commerce, with a recommendation for a federal criminal fine of $150 million.

 

Celexa and Lexapro are anti-depressants that until recently had not been approved for pediatric use. The allegations were that Forest paid unlawful kickbacks in various forms to physicians as incentives to prescribe those two medications for unapproved uses. The allegations for Levothroid were that Forest continued to distribute it after the FDA removed its classification as a covered outpatient drug in August, 2001, thereby resulting in false claims filed under state Medicaid programs.

 

This settlement resolves two qui tam cases in which Wisconsin was named as a co-plaintiff state. Wisconsin filed a Notice of Intervention under its False Claims Act in U.S. ex rel. Gobble v. Forest Labs on February 13, 2009. Wisconsin declined in U.S. ex rel. Piacentile v. Forest Labs, not on the merits of the allegations, but because the relator in Gobble had filed first.

 

“This settlement tells those who choose to participate in the Medicaid program that they have to scrupulously follow the rules,” said Van Hollen. “We have to use our limited taxpayer dollars wisely and effectively.”