Fifty-four lawsuits, mostly involving suicides and attempted suicides by teenagers in various parts of the country, accuse the New York-based pharmaceutical company of concealing a negative pediatric study on Celexa, duping physicians about the drug’s clinical trials, and targeting children in aggressive promotions of Celexa and a sister drug, Lexapro. Four of the cases were settled Friday, and two additional cases were settled in recent weeks. A surge of related settlements, which could total millions of dollars, is expected in the months ahead as the pharmaceutical company attempts to move beyond the controversy surrounding its marketing of antidepressants to children.
Since 2004, pharma has paid over $7 billion in fines and penalties, but even these figures barely dent profits. The $2.3 billion fine Pfizer paid in September 2009 for the way one of its subsidiaries marketed Bextra, the non-steroidal anti-inflammatory drug, and three other drugs, was the biggest ever paid by a corporation in the US. Yet the fine was just 14 per cent of $16.8 billion revenue from the drugs from 2001 to 2008, little more than the price of doing business.
Forest Labs (FRX) appears to have initially underestimated how much it needed to pay the feds to go away: In 2009, the company said it had set aside $170 million in case it needed to settle a Department of Justice investigation of the kickbacks it paid in its marketing of Celexa and Lexapro, two antidepressants. Today, the company paid $313 million to wrap up the probes. Forest’s management is used to lavish spending, however, as the whistleblower complaints behind the settlement allege. The meat of Forest’s wrongdoing is that the company promoted Celexa for children even though the FDA had specifically rejected the drug for kids, and even though European data showed it was not useful in youths. The company did something similar with Lexapro — one pharmaceutical sales rep recommended crushing up Lexapro into apple sauce in order to make it more palatable to children.
Forest Laboratories Inc. (FRX) will pay $313 million to settle criminal and civil charges that it improperly marketed antidepressants for use in children and distributed an unapproved thyroid drug, the Justice Department announced Wednesday….The settlement also covers civil charges that Forest improperly promoted Celexa and another antidepressant, Lexapro, for pediatric use, which had not been approved by the Food and Drug Administration. Forest’s improper promotion campaign took place from 1998 until at least 2005, the department alleged.
Sixteen months after 7-year-old Gabriel Myers committed suicide while taking psychotropic drugs, the state of Florida has banned allowing any children in the state’s custody from participating in clinical drug trials.