The makers of Celexa and Lexapro intentionally misled the medical community about the safety of their popular antidepressants for children, according to allegations raised in a recent lawsuit that indicates the drug maker illegally promoted the medications for uses that were not approved by the FDA.
A complaint (PDF) was filed against Forest Pharmaceuticals earlier this year in the U.S. District Court for the District of Massachusetts, seeking class action status on behalf of all individuals who purchased or paid for prescriptions of Celexa or Lexapro.
In response to an attempt by Forest to have the case dismissed, plaintiffs filed a brief (PDF) on June 13, indicating that the case should be allowed to move forward.
According to allegations raised in the case, Forest engaged in deceptive and unlawful marketing that was purposefully designed to deceive the public about the safety of Celexa and Lexapro for children, and which violated the law so that the drug maker could sell the medications it knew had safety problems for children. Forest allegedly bribed doctors, rigged clinical trials and unlawfully marketed Celexa and Lexapro to get prescriptions for children.
“By using fundamentally misleading drug labels, the ‘endorsements’ of paid opinion leaders, gerrymandered clinical trials, and a legion of specially trained sales personnel, Forest misled consumers and the medical community about Celexa’s and Lexapro’s efficacy in treating pediatric depression,” the lawsuit states. “The clinical trials that examined whether the antidepressants Celexa and Lexapro are effective at treating adolescent major depressive disorder (“MDD”) indicate that Celexa and Lexapro are no more effective clinically than a sugar pill.”
In September 2010, Forest pled guilty to charges of illegally marketing the drugs, and a felony count of obstructing justice. The company agreed to pay more than $313 million as part of a whistleblower lawsuit.
The charges stemmed from off-label promotions Forest Pharmaceuticals now admits that it conducted following a study involving Celexa. The company trumpeted the positive results of the study while failing to mention negative results during a similar study conducted in Europe. The company also gave kickbacks to doctors and others to prescribe both Celexa and Lexapro and had its sales representatives and outside speakers talk to pediatric specialists about prescribing both drugs to adolescents and children. –
While Forest admitted to illegal marketing of Celexa and Lexapro, the company has asked that the lawsuit be dismissed, saying plaintiffs waited too long to file a claim. The company argues that under statute of limitation laws, the plaintiffs knew or should have known of their actions involving Celexa and Lexapro as early as 2005, when charges were first brought against the company. However, plaintiffs maintain that does should not bar the filing of the class action lawsuit at this time.
Their opposition brief notes that statute of limitations is suspended when a lawsuit seeks class action status in case it is denied. That is what happened when a complaint was first filed in 2009, the brief states.
Forest reached a number of Celexa and Lexapro lawsuit settlements in 2010 over claims that the drugs caused suicidal tendencies in children.
More than 50 suicide lawsuits over Lexapro and Celexa alleged that children taking the two drugs were prone to violence and suicide. The plaintiffs in those cases claimed that Forest knew from studies that there was a higher risk of suicide associated with the drugs when used by children, but failed to warn patients or doctors. The lawsuits charge the company with failure to warn, negligence and fraud.
In 2005, the FDA required that a black box warning be placed on a wide variety of antidepressants, warning that they could cause increased thoughts of suicide in children and adolescents. Both Celexa and Lexapro were required to carry those warning. The suicides that sparked the lawsuits predated the FDA-required label change.