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Forest Labs Accused by U.S. of Paying Drug Kickbacks (Update2)

By Cary O’Reilly

Feb. 25 (Bloomberg) -- Forest Laboratories Inc. illegally promoted antidepressant drugs for unapproved use in children and paid kickbacks to doctors to prescribe them, the U.S. Justice Department said in a lawsuit.

The company is accused of violating the False Claims Act in its marketing of Celexa and Lexapro for “off-label” uses, and of paying kickbacks, the government said in the complaint unsealed today in federal court in Boston.

Forest induced doctors with cash payments disguised as grants or consulting fees, meals, entertainment and other things of value, all in violation of federal anti-kickback laws, according to the complaint. The company also misled doctors by promoting some studies of Celexa while hiding a less favorable one, it said.

“By knowingly and actively promoting these antidepressants for off-label pediatric use without disclosing the results of the negative pediatric study, and by paying kickbacks, Forest caused false claims to be submitted to federal health care programs,” Massachusetts U.S. Attorney Michael Sullivan said in the complaint.

Triple Damages

The company caused “thousands of false and fraudulent claims” to be filed over a five-year period, the government said. Under the False Claim Act, the U.S. can be awarded triple damages, plus civil penalties of as much as $11,000 for each violation.

Frank Murdolo, a spokesman for New York-based Forest, didn’t return a phone call seeking comment.

One study found Celexa no more effective than a placebo for use in children, and more patients taking the drug attempted suicide or reported suicidal thoughts, according to the complaint.

Lexapro, with some $2 billion in annual sales, is approved in the U.S. to treat generalized anxiety disorder and major depressive disorder in adults. Doctors can prescribe medicines for any use, but it is illegal for pharmaceutical companies to promote them for uses not approved by the U.S. Food and Drug Administration.

Along with the Alzheimer’s drug Namenda, Lexapro accounts for 80 percent of Forest’s revenue. The Supreme Court on Feb. 23 rejected a bid by Forest to stop a rival from seeking judicial confirmation that its generic version of Lexapro wouldn’t infringe the patent, which expires in 2012.

Forest fell $1.29, or 5.3 percent, to $23.14 in New York Stock Exchange composite trading. The shares have dropped 45 percent in the past year.

The case is U.S. v. Forest Laboratories, 03-10395, U.S. District Court, District of Massachusetts (Boston).

To contact the reporter on this story: Cary O’Reilly in Washington at caryoreilly@bloomberg.net.

Last Updated: February 25, 2009 17:19 EST

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