Birth Defect Risks Associated With Zoloft. The parents of a little boy who died from the birth defect, anencephaly, have filed suit against Pfizer Inc., claiming the antidepressant, Zoloft, caused the disorder. According to a report from Courthouse News Service, Susan and James Hodge allege Pfizer knew of birth defect risks associated with Zoloft but did nothing to alter the drug’s prescribing information.
Zoloft belongs to a class of antidepressants known as selective serotonin inhibitors, or SSRIs. Other SSRIs include Prozac, Paxil, Celexa, Lexapro and others. In 2006, the U.S. Food & Drug Administration (FDA) asked the manufacturers of several SSRI antidepressants to add information to their labels describing the potential risk of persistent pulmonary hypertension of the newborn (PPHN) after a study in the New England Journal of Medicine (NEJM) found a six-fold increased risk of the disorder among infants born to mothers who took an antidepressant in the last trimester of pregnancy.
A 2007 study published in the Harvard School of Public Health that drew on data from the Centers for Disease Control’s National Birth Defects study also found that anencephaly was one of three neural tube defects most often associated with a mother’s use of an SSRI antidepressant.
Anencephaly Is Always Fatal
According to the Hodge’s lawsuit, before taking Zoloft, Susan “relied upon the fact that congenital birth defects … were not listed or emphasized on the Zoloft monograph and/or drug information as a basis to believe that Zoloft was safe for use during her pregnancy.”
The Hodges’ son, Dillon, was born on October 1, 2009 with anencephaly, a birth defect “generally described as the absence of a large part of the brain and skull,” according to their complaint. Anencephaly is always fatal, and Dillon died the day after his birth.
“During the entire time Zoloft has been on the market in the United States, FDA regulations have required Pfizer to issue stronger warnings whenever there existed reasonable evidence of an association between a serious risk and Zoloft,” the complaint states. “The regulations specifically state that a casual link need not have been proven to issue the new warnings. Further, the regulations explicitly allowed Pfizer to issue such a warning without prior FDA approval.”
“Thus, prior to the mother plaintiff’s pregnancy, Pfizer had the knowledge, the means, and the duty to provide the medical community and the consuming public with a stronger warning regarding the association between Zoloft and congenital birth defects,” it continues.
The Hodges seek punitive damages for product liability, negligence, fraud, breach of warranty, unjust enrichment, false advertising and wrongful death, according to Court House News.
The Hodges filed their lawsuit in Cuyahoga Court of Common Pleas in Ohio.