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US justice department sues company for off-label promotion of antidepressants for children

BMJ 2009; 338 doi: (Published 25 March 2009) Cite this as: BMJ 2009;338:b1222
  1. Janice Hopkins Tanne
  1. 1New York

    The United States Department of Justice filed a civil complaint last month against Forest Laboratories in a district court in Massachusetts, alleging that the company violated the federal False Claims Act.

    The department’s complaint says that the company marketed its antidepressants citalopram (marketed in the US as Celexa) and escitalopram oxalate (Lexapro) for use in children when the drugs were not approved for such use, that the company paid inducements to doctors to promote use of the drugs in children, that the company failed to disclose a study showing that Celexa was not effective in children, and that the government was defrauded of millions of dollars because federal health insurance programmes such as Medicaid paid for prescriptions for the drugs that were not covered by off-label paediatric use.

    Under the statute, the justice department says, “the government can recover treble damages and $5500 [£3800; €4000] to $11 000 for each false or fraudulent claim filed. If the government is successful in resolving or litigating its claims, a proper whistleblower can receive a share of between 15% and 25% of the amount recovered.” Two whistleblowers apparently helped bring the complaint.

    Forest Laboratories issued a statement saying that it was currently reviewing the government’s complaint and would respond …

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