Forest Laboratories manufactures an antidepressant drug citalopram under the brand name Celexa. Celexa is designed to treat depression and other mood disorders. The U.S. Food & Drug Administration (FDA) approved Celexa for use in adults. However, it is not approved for use in children and teens. Forest Laboratories has been illegally marketing Celexa for children. In addition, it has offered doctors bribes and other kickbacks to prescribe Celexa for children and teens. Forest Laboratories also concealed a study about the negative effects of Celexa on children and teens.
For these actions, the U.S. Department of Justice (DOJ) is investigating Forest Laboratories. Forest Laboratories is being charged with fraud and for violating the False Claims Act. The fraud and false claims charges stem from their concealment of the negative Celexa study. The study found that Celexa was actually ineffective in treating children and teens for depression. What is even worse, the study showed that Celexa actually INCREASED the risk of suicidal thoughts and behavior in children and teens.
Even knowing about the study, Forest Laboratories still encouraged “off label” use of Celexa. “Off-label” use means illegally marketing drugs for uses, which they are not approved for. Doctors prescribed Celexa for children, which cost government health plans such as Medicare and Medicaid thousands of dollars. The DOJ is seeking to recover the money the government programs spent on Celexa, times three, to account for the total damages to the government. Forest Laboratories may be liable for millions of dollars of damages. Each violation can be a civil penalty of $11,000.
Federal prosecutors are also investigating the kickbacks Forest Laboratories gave to doctors to encourage Celexa prescription. Such kickbacks included baseball tickets, paid vacations and gift certificates. Forest Laboratories also ran “seeding studies,” which are marketing efforts to promote Celexa’s use by doctors. Ironically, doctors are allowed to prescribe drugs to children, even if the federal government does not approve them. Doctors were allowed to prescribe Celexa to children, but it was illegal for Forest Laboratories to actively market and encourage doctors to make such prescriptions.
Forest Laboratories’ behavior only gets worse. Instead of disclosing the negative results of the study, Forest financed its own study for Celexa. This study found Celexa was effective. Forest Laboratories then used the positive study to market Celexa. Motivated by greed and profit, Forest Laboratories put children’s lives at risk. Forest Laboratories knew Celexa was dangerous for children and teens and then did nothing. In fact, they took deliberate steps to conceal the danger and manufactured a study to say Celexa was safe and effective.
Forest Laboratories was looking to protect its profit and stock prices, not the American public. Doctors, who accepted kickbacks and bribes, are just as reprehensible. They put their own patients’ lives in danger for a fancy meal and a nice vacation. Hopefully these lawsuits and investigations will be successful; Forest Laboratories will be forced to pay huge fines and doctors and top Forest Laboratories’ executives will go to prison, because they put profit before patients.