Plaintiffs Hoping for More Paxil Birth Defects Settlements

Boston, MAAlthough very little information has been released concerning the settlement of Paxil birth defects lawsuits, news reports indicate that approximately 190 cases have been settled while another 100 are in various stages of settlement.

At issue in the lawsuits is whether or not Paxil caused the birth defects of infants whose mothers took the antidepressant while pregnant. Scientific studies concerning the link between Paxil and other selective serotonin reuptake inhibitors (SSRIs) to birth defects have returned mixed results. Further studies have suggested a link between SSRIs and behavioral problems, withdrawal symptoms and developmental delays.

GlaxoSmithKline, however, has defended its drug and its own actions regarding Paxil. A spokeswoman for GlaxoSmithKline, Sarah Alspach, said in an e-mail statement that the company agreed to settle to avoid the costs and uncertainties of ongoing litigation

"GSK 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," Alspach wrote, as published in the Legal Intelligencer on 6/23/10.

Plaintiffs, however, disagree. They argue that GlaxoSmithKline failed to adequately warn physicians and patients about the risks of birth defects when babies are exposed to Paxil prior to birth. They allege those birth defects include Persistent Pulmonary Hypertension of the Newborn (PPHN) and atrial or septal defects—holes in the heart.

Babies born with these defects often face lengthy hospital stays and multiple surgeries.

The plaintiff's claims appear supported by the US Food and Drug Administration (FDA), which in 2005 warned pregnant women and their physicians about the risk of heart defects in newborns when exposed to Paxil (known generically as paroxetine) prior to birth.

According to the 12/08/05 FDA news release, the decision to update the labeling on Paxil resulted from two studies that found that women who used Paxil during the first trimester of pregnancy were one-and-a-half to two times as likely to give birth to babies with heart defects than women who took other antidepressants or women in the general population.

No further information has been reported on the remaining Paxil lawsuits.