Paxil Birth Defect Cases Continue on the Road to Settlement

Washington, DCExpectant mothers who suffer from depression face a difficult decision: Paxil and other antidepressants have been linked to an increased risk of birth defects, yet many pregnant women are unable to manage their depression without medication. While the debate rages on over the best course of action, it seems that the US Food and Drug Administration (FDA) is content with allowing Paxil to continue on the market—and for pregnant women to continue using it on doctors' orders—in spite of the risks.

According to the 6/23/10 issue of FiercePharma, in an article sourced from a recent edition of the Legal Intelligencer, Paxil manufacturer GlaxoSmithKline (Glaxo) has agreed to settle about 190 cases. Another 100 cases are in various stages of settlement. A judge who was assigned the responsibility of coordinating the mass tort case reportedly told the Legal Intelligencer that Glaxo's position was "to try and settle what they can and to settle in groups."

The various settlements follow Glaxo's loss of a case in October of last year, when a jury awarded $2.5 million to one plaintiff. Since that time additional cases have been settled in spite of litigation defenses in an effort to avoid the costs and other factors associated with ongoing litigation, according to a Glaxo spokesperson.

Bloomberg News reported at the end of last year that Glaxo has paid almost $1 billion to resolve Paxil lawsuits since the antidepressant first arrived in the US market in 1993. Some $200 million was paid to settle various addiction and Paxil birth defect cases.

At the time, Glaxo would not comment specifically on the $1 billion figure. In an email statement to Bloomberg, Glaxo spokesperson Sarah Alspach said, "Paxil has been on the market in the US since 1993. Like many other pharmaceutical products, it has been the subject of different kinds of litigation over the years. It would be inappropriate and potentially misleading to aggregate payments in these various types of litigation."

Meanwhile, in spite of various lawsuits stemming from Paxil, Glaxo maintains it handled safety well. A spokesperson for Glaxo reportedly told the Legal Intelligencer, "[Glaxo] believes it acted properly and responsibly in conducting its clinical trial program for Paxil, in marketing the medicine, in monitoring its safety once it was approved for use, and in updating pregnancy information in the medicine's label as new information became available."