Paxil maker GlaxoSmithKline has settled a class action lawsuit brought by insurance companies over the drug’s suicide risks, but now faces two other suits brought by families in West Virginia who claim the drug caused their children’s birth defects.
The $40 million settlement was reached in a class action lawsuit that alleged Glaxo withheld negative information about the safety and efficacy of Paxil for teenagers and children. Under the terms of the settlement, 42,000 health plans that paid for a Paxil prescription for use by a minor between January 1998 and December 2004 can recover 40 percent of their actual costs of the drugs prescribed to children and adolescents diagnosed with a major depression. If the diagnosis was unknown, the can recover 15 percent of the cost.
This is the second Paxil class action lawsuit that Glaxo has settled recently. In 2007, Glaxo agreed to pay $63.9 million to settle a lawsuit filed by consumers. The company did not admit wrongdoing in either lawsuit.
Several studies have linked Paxil and similar antidepressants to suicide in teenagers. Last year, the Food & Drug Administration (FDA) ordered Glaxo and the makers similar drugs to include a black box warning – the agency’s strongest safety notice – about their risks to children on the drugs’ labels. Paxil is not approved for use in children, but doctors are free to prescribe medications in anyway they see fit.
Meanwhile, Glaxo was just named a defendant two new lawsuits filed in West Virginia involving birth defects allegedly caused by Paxil. Both suits were filed by families who claim that the heart birth defects suffered by their children were the result of their mothers’ Paxil use during pregnancy. The lawsuits claim the women took the drug believing it to have no adverse side effects because company promotions touted the drug as a safe alternative for pregnant women. When they were born, both children suffered from congenital injuries and disorders and birth defects, as well as heart defects and developmental delays, the suits state.
The lawsuits claims that Glaxo knew that Paxil was associated with birth defects, but did not inform doctors of the risks until 2005 when it revised Paxil’s label indicating the dangers. The lawsuits are seeking unspecified compensatory damages, pre- and post-judgment interest, court costs, a refund of all costs associated with the purchase of Paxil and disgorgement of the company’s profits from Paxil.
