PA Jury Finds GSK Failed To Warn About Paxil Birth Defects; Awards Family $2.5M

A Pennsylvania jury found that GlaxoSmithKline (GSK) failed to warn doctors about the risks of pregnant woman taking its antidepressant drug, Paxil, and awarded the family of a child born with heart defects $2.5 million in damages. It is the first case of about 600 which have been filed against the pharmaceutical giant over Paxil's link to birth defects.

Pennsylvania Paxil injury lawsuit

This Pennsylvania Paxil lawsuit is the first of many lawsuits set for trial over birth defects caused when mothers took Paxil while pregnant. In this Pennsylvania lawsuit, the Kilker family sued GSK after their son, Lyam, was born with serious heart defects. They alleged that the drug manufacturer failed to do adequate studies before putting Paxil on the market and knew about the risks of birth defects for women taking Paxil while pregnant as far back as 1980, but concealed those risks in order to increase profits – which were nearly a billion dollars last year for Paxil sales alone.

A jury agreed and awarded them $2.5 million in damages for medical care, which is more than double the amount they had asked for – sending a message to GSK that the remaining 600 Paxil lawsuits may cost the company dearly.

Did GSK hide the risks of Paxil?

It seems that way. GSK paid the State of New York $2.5 million in 2004 to resolve claims alleging that the drug company knew that Paxil use in teens caused suicidal behavior and was forced to disclose previously concealed studies on the issue.

Paxil lawyers say that only after the New York State Paxil settlement did the company warned doctors about Paxil use and birth defects in September of 2005.

The U.S. Food & Drug Administration (FDA) also issued a Public Health Advisory in December 2005 about the risk of heart birth defects and then another in July 2006 warning of an increased risk of PPHN – or Neonatal Persistent Pulmonary Hypertension – by pregnant women taking Paxil and other SSRI (Selective serotonin reuptake inhibitors) antidepressants such as Fluvoxamine, Celexa (citalopram), Lexapro (escitalopram), Zoloft (sertraline), Prozac (fluoxetine) and Symbyax (olanzapine and fluoxetine).

Paxil use has been linked to serious birth defects such as cardiac, pulmonary, neural-tube defects (brain and spinal cord), craniosynostosis (abnormally shaped skull), infant omphalocele (abdominal wall defects), club feet and anal atresia.