GlaxoSmithKline has reportedly agreed to pay more than $1 billion to settle hundreds of Paxil birth defect lawsuits, as part of an effort to resolve their Paxil and Avandia litigation.
Bloomberg news reports that a $2.4 billion set aside that Glaxo announced earlier this month to settle outstanding liabilities includes the settlement of Paxil birth defect lawsuits brought by parents who say that use of the antidepressant during pregnancy caused persistent pulmonary hypertension in newborns (PPHN) or other problems for their babies. The company, which announced the set aside as part of its second-quarter earnings report, has refused to confirm the $1.14 billion settlement and has given no details about how the set aside will be spent.
Paxil (paroxetine) is a selective serotonin reuptake inhibitor prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.
There are an estimated 800 Paxil lawsuits over birth defects filed against the drugmaker as part of a mass tort in Philadelphia, all involving allegations that the company failed to warn consumers and doctors that use of Paxil during pregnancy could lead to congenital heart defects in newborns. The lawsuits also claim that the company hid test results and purposefully misled doctors.
In December 2005, the FDA issued an alert about the risk of birth defects from Paxil after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label to include information about the risk of birth defects from Paxil side effects.
In October, Glaxo lost the first Paxil birth defect trial, when a Philadelphia jury awarded $2.5 million in compensatory damages to the family of a child born with three heart defects. While Glaxo initially indicated they would appeal the verdict, the case was among nearly 200 the company said it settled last month.
The legal charge announced by Glaxo also includes settlements for thousands of Avandia lawsuits brought by plaintiffs who say the diabetes drug causes heart attacks. Earlier this month, it was reported that the company was prepared to settle 10,000 of about 13,000 Avandia lawsuits. The set aside also includes a settlement for an antitrust lawsuit between GlaxoSmithKline and Apotex over a generic version of Paxil, and would include a $750 million settlement with the Department of Justice over problems at a former Paxil and Avandamet production plant in Cidra, Puerto Rico.