Parents Say Paxil Use During Pregnancy Caused Son's Injuries

LexisNexis Legal News and Litigation Reports
Mealey's Litigation Report: Antidepressant Drugs
August, 2006

PHILADELPHIA - A Texas couple sued the manufacturer of Paxil on July 28, claiming that the woman's use of the drug while pregnant caused their infant son's injuries, which required multiple open-heart surgeries and the installation of a pacemaker (Adrian Vasquez, et al. v. SmithKline Beecham, No. 060703453, Pa. Comm. Pls., Philadelphia Co.).

In their complaint filed in the Philadelphia County Court of Common Pleas, Anthony and Matilda Vasquez allege that Paxil maker GlaxoSmithKline (GSK) knew or should have known that the use of the antidepressant during pregnancy increased the risk of congenital heart defects and that the company should have issued stronger warnings when reasonable evidence of an association became available. 

"The seriousness of these birth defects are such that, at the very first sign of danger, GSK should have issued a strong warning," the Vasquez's attorney, Karen Barth Menzies of Baum Hedlund in Los Angeles, said in a press release.  "Over 1 percent - or 40,000 - pregnant women in the U.S. are taking antidepressants.  Given the popularity of Paxil, thousands of babies are at risk."

The Vasquezes complain that their child underwent his first of three open-heart surgeries eight days after he was born on April 19, 2004, and that they have been informed that as Adrian grows he will need other surgeries to maintain his pacemaker.  In addition, they say that their son may eventually need a heart transplant. 

Studies Revealed Risks

According to the plaintiffs, GSK failed to properly warn about the risk of birth defects associated with Paxil, even though a 2003 GSK study found that children born to women using Paxil during pregnancy were more than twice as likely to suffer from congenital malformations.  Moreover, a study published in the journal Pharmacoepidemiology and Drug Safety in 2005 revealed an association between Paxil and congenital malformations in mothers taking Paxil during the first trimester.

Furthermore, the manufacturer in September 2005 sent a "Dear Doctor" letter to physicians to inform them that Paxil was associated with a higher risk of congenital malformations when compared to other antidepressants, the plaintiffs say.

The plaintiffs seek damages based on claims of negligence, negligence per se, negligent pharmaco-vigilance, failure to warn and breach of express and implied warranty.

Cara Luther of Baum Hedlund in Philadelphia and Ronald L.M. Goldman and Karen Barth Menzies of Baum Hedlund in Los Angeles represent the Vasquezes.

 

 

Print This Article