A federal judge will allow a mother’s Paxil birth defects lawsuit to proceed over objections that it should be barred by a state tort reform law.

Plaintiff Kathryn K. is claiming that defendant GlaxoSmithKline LLC’s drug Paxil caused her child’s birth defects.

Judge Edmund A. Sargus determined that Kathryn’s claim had accrued when her child was born in 2001, prior to a 2005 amendment to the Ohio Product Liability Act that abolished common law liability claims in that state. Therefore the later change in the law did not retroactively bar her already-existing claim.

GSK had argued that Kathryn’s claim had not accrued until after the 2005 amendment, when the company alerted the medical community to the risk of birth defects associated with Paxil.

But Judge Sargus noted that a discovery rule in the 2005 Tort Reform Act allows the date of accrual for a bodily injury claim to be set by the date it was reasonable for the injured person to discover the relationship between the injury and the product at issue. In Kathryn’s case, the judge determined that date was the date her child was born with birth defects.

Paxil Birth Defects Allegations

Kathryn alleges in her birth defects lawsuit that her child was born in 2001 with a ventricular septal defect and infant respiratory distress syndrome. Kathryn now attributes those birth defects to the Paxil she took prior to the child’s birth.

Kathryn says that GSK knew about the risk of Paxil birth defects from the results of pre- and post-marketing studies, which had showed a link between taking Paxil during pregnancy and a significant increase in cardiac birth defects. Despite that knowledge, she says, GSK promoted Paxil as being safe and effective, and even made affirmative misrepresentations that presented Paxil as being safer than it actually was.

The Paxil Birth Defect Lawsuit is Case No. 2:14-CV-2164, in the U.S. District Court for the Southern District of Ohio.

What is Paxil?

Paxil, also known as paroxetine, is an antidepressant medication approved by the FDA to treat depression, anxiety disorder, obsessive-compulsive disorder, premenstrual dysphoric disorder, and post-traumatic stress disorder.

Paxil is one of a class of antidepressants known as selective serotonin reuptake inhibitors, or SSRIs. A recent study of the risks of birth defects associated with several different SSRIs confirmed what had been previously discovered about paroxetine.

The study found that birth defects occurred 2 to 3.5 times more frequently in babies born to women taking paroxetine during pregnancy. Furthermore, the study found paroxetine was associated with a wider variety of birth defects including anencephaly, heart defects, and abdominal wall defects.

The FDA has also issued a Drug Safety Communication warning about the link between SSRIs like Paxil and congenital birth defects. The 2005 communication cites several studies showing an increase in the risk of congenital heart defects in children of mothers who took paroxetine during pregnancy.

The agency encouraged physicians to consider discontinuing paroxetine treatment in patients who are pregnant or are planning to become pregnant. Women who are taking paroxetine and are pregnant or planning on pregnancy should consult their physician about the risk of birth defects.