Paxil Settlements Reached in Hundreds of Birth Defect Lawsuits

GlaxoSmithKline has agreed to settle Paxil birth defect lawsuits brought on behalf of nearly 200 people. The settlements come after the company was hit with a $2.5 million verdict in the first case to go to trial last year. 

There are an estimated 600 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.

According to an order signed by Judge Sandra Mazer Moss, who is overseeing the Paxil litigation, GlaxoSmithKline has agreed to settle 190 of those cases. In addition, according to a report by The Legal Intelligencer, Paxil attorneys have settled about another 100 cases, some of which were not yet filed.

In October, a Philadelphia jury ruled against Glaxo, awarding $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 those settled last week. However, no details on any of the Paxil settlement terms have been disclosed.

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.

The use of Paxil during pregnancy has been linked to an increased risk of persistent pulmonary hypertension in newborns (PPHN) and other heart problems. In lawsuits pending throughout the United States, plaintiffs allege that GlaxoSmithKline hid test data and misled doctors and consumers about the risk.

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.

Not counting the 190 cases just settled, GlaxoSmithKline has reportedly paid about $1 billion to settle Paxil lawsuits, including claims that the drug also causes suicides, addiction and other problems, in addition to birth defects.