Lexapro and Celexa, both antidepressants, have been at the center of multidistrict litigations (MDL) against Forest Laboratories. In lawsuits consolidated in MDL Case No. 2067 entitled In Re Celexa and Lexapro Marketing & Sales Practices Litigation, pending in the U.S. District Court for the District of Massachusetts, plaintiffs allege that the benefits of Celexa and Lexapro in children had been exaggerated by Forest, according to Law360.
Lexapro had been approved by the U.S. Food and Drug Administration (FDA) for the treatment of depression in patients 12 years of age and older. Celexa has been approved since 1998 for patients 18 years of age and older. In addition, a lawsuit was filed by the U.S. Justice Department for “off-labeling,” which means it is illegal for a pharmaceutical company to promote a drug for uses that have not been approved by the FDA. According to The Wall Street Journal, the FDA never approved the drugs (Lexapro and Celexa) for use in children.”
In 2002, the FDA noted that Celexa is no more effective than a placebo in treating children with depression. The plaintiffs in the MDL case claimed that Forest had misled doctors concerning the benefits of the antidepressants for children, and had “implemented a false marketing strategy,” according to Law360. Forest was also accused of violating the False Claims Act by violating anti-kickback laws, paying doctors to prescribe Lexapro and Celexa to children and covering up medical studies that concluded these drugs were not effective medications for children, Law360 reports.
Forest was penalized for only publicizing positive Celexa study results in adolescents while knowingly withholding negative results. A settlement was reached in 2014 in Missouri over Celexa and Lexapro claims, and Forest agreed to pay between $7.7 million and $10.4 million, reports Law360.