Even though Lexapro and Celexa were both proven to promote suicidal thoughts in children, Forest Laboratories chose to market its antidepressants to pediatric patients anyway, prosecutors at the U.S. Justice Department have charged.
According to the Wall Street Journal (WSJ), the same prosecutors have charged that Forest Labs also violated anti-kickback laws by paying doctors to prescribe Lexapro and Celexa to vulnerable, pediatric patients. A lawsuit filed by the department now accuses the drug maker of violating the False Claims Act when it marketed the drug, The civil complaint also accuses Forest of covering up a medical study that concluded that Lexapro and Celexa were not effective medications for children, said WSJ. The complaint was unsealed in Boston federal court yesterday.
According to Bloomberg.com, the complaint charges that Forest was unwavering in its marketing of the drugs. Knowing that they were ineffective in children and could also cause suicidal thoughts in pediatric patients, Forest went ahead and promoted Lexapro and Celexa for use in children, going so far as to cite a study that was more conducive to its needs and hiding the negative findings. Meanwhile, the U.S. Food and Drug Administration (FDA) never approved the drugs for use in children.
According to the DOJ, Forest’s bribes and inappropriate marketing resulted in false claims submission for reimbursement to federal health care programs said the Journal. Bribes included not just cash payments—falsely described as grants and consulting fees—but pricey meals and other expensive gifts which violated anti-kickback laws, said Bloomberg. “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, reported Bloomberg.
Now, under the federal False Claims Act, the DOJ is looking for triple the financial damages from Forest in addition to other penalties; the total compensation sought is unknown, said the Journal. Bloomberg noted that under the Act, the government is eligible to receive treble damages and civil penalties of up to $11,000 per violation.
This case and others may be evidence that the DOJ is making a concerted effort to crack down on the illegal drug marketing practices. The Journal pointed out that just last week, the DOJ joined a whistle blower lawsuit against Johnson & Johnson in which the drug maker is charged with illegally marketing its cardiac medication Natrecor. Also, last month, Pfizer Inc. and Eli Lilly & Company both agreed to payouts in two separate cases involving illegal marketing, said the WSJ. Pfizer agreed to pay over $2 million in response to charges it illegally promoted it now-withdrawn painkiller Bextra. Eli Lilly agreed to pay $1.4 billion in fines to settle similar claims over its antipsychotic Zyprexa.
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