The Department of Justice (DOJ) is suing Forest Laboratories over the alleged promotion of Celexa and Lexapro off-label, for pediatric use. Forest also paid kickbacks to physicians in return for prescribing the drugs, the DOJ said in a statement.
The allegations, filed in a Massachusetts federal court yesterday, claim Forest hoodwinked physicians by failing to properly disclose results of a negative study regarding Celexa. That study found the drug to be no more effective than a placebo for pediatric use, and that patients taking Celexa displayed an increased suicidality risk.
Forest reps provided physicians with “various forms of illegal remuneration” in exchange for scripts, including “cash payments disguised as grants or consulting fees, expensive meals and lavish entertainment and other valuable goods and services,” the DOJ said, all of which are in violation of the federal anti-kickback statute.
In a statement on Forest’s website today, the company acknowledged the investigation—11 states and the District of Columbia have filed as plaintiffs—and said the company is “currently reviewing the complaint and will respond to this action at the appropriate time.” Frank Murdolo, a Forest spokesperson, was not able to comment beyond the company statement.
Prior to filing a complaint with the US Attorney’s Office for the District of Massachusetts, DOJ intervened in two separate whistleblower actions against Forest under the False Claims Act’s qui tam provision, which allows individuals to file a lawsuit on behalf of the US against those who have defrauded federal funds. Individuals filing qui tam suits are rewarded with 15% to 25% of the proceeds from a successful suit, and up to 30% if the government declines the suit and the individual pursues the action alone.
In the case of Forest, DOJ alleges that “federal health care programs have paid thousands of false and fraudulent claims for Celexa and Lexapro prescriptions that were not covered for off-label pediatric use and/or were ineligible for payment as a result of illegal kickbacks paid by Forest,” according to the DOJ statement.