Legal News

Qui Tam Slam: NY Drugmaker Sued Over Alleged Kickback Scheme

By Ashby Jones

Here’s an allegation that might make you reach for your antidepressants: Federal authorities in Boston have accused Forest Laboratories of improperly marketing its antidepressant drugs Celexa and Lexapro for use in children, and of paying kickbacks to encourage doctors to prescribe the drugs for such use.

The government’s civil complaint, originated by whistleblowing former company officials as a false-claims or “qui tam” action, was unsealed Wednesday. The suit alleges that Forest failed to disclose a medical study that determined the company’s antidepressant drugs were ineffective for pediatric use. That study also found that the drugs could cause suicidal thoughts in children. Click here for the WSJ story; here for the NYT’s; click here for the complaint.

Despite the study’s negative findings, the complaint alleges that Forest promoted its antidepressants for pediatric use, citing instead a different study. The Food and Drug Administration hasn’t approved Celexa and Lexapro for pediatric use. The Justice Department alleges that Forest’s improper behavior caused false claims to be submitted to federal health-care programs for reimbursement.

In addition to the marketing allegations, government lawyers allege that Forest lavished doctors with cash payments, expensive meals and other valuables to induce them to prescribe the antidepressants to children. The lawsuit alleges the drug maker disguised the cash payments as grants and consulting fees.

Frank Murdolo, a spokesman for Forest Labs, told the Journal that the company hadn’t yet seen the lawsuit, and that it would respond once it had. But Thursday, the company issued a statement on its Web site, which reads, in part: “Forest is committed to adhering to the highest ethical and legal standards, and off-label promotion and improper payments to medical providers have consistently been against Forest policy. Forest is currently reviewing the complaint and will respond to this action at the appropriate time.”

The government’s complaint is the latest in a series alleging that drug companies have promoted products for off-label uses. Last week, the government joined two whistleblower lawsuits alleging that Johnson & Johnson illegally marketed its heart drug Natrecor. In January, Pfizer said it would pay $2.3 billion to settle charges that it illegally promoted Bextra, a painkiller now off the market.

Full post as published by Law Blog - WSJ.com on February 26, 2009 (boomark / email).