September 5, 2012 — Denise and Nicholas Ciccone have filed a Zoloft birth defect lawsuit on behalf of their daughter, Noelle, who was born with clubfoot and truncus arteriosus after her mother took Zoloft (sertraline) during pregnancy.

The lawsuit alleges that “Pfizer knew or should have known that children were being born with congenital birth defects, including heart defects, club foot and other cardiopulmonary conditions to women who took Zoloft during pregnancy.”

Noelle suffers from clubfoot affecting her right foot. Children with this defect have underdeveloped structures in the lower leg that causes the foot to be turned inward and downward at a sharp angle, resembling a club. It often causes severe impairments to walking ability. Noelle also suffers from a heart defect called truncus arteriosus, in which the heart develops with one single blood vessel connected to the right and left ventricles instead of two vessels (pulmonary artery and aorta). Children with truncus arteriosus usually must undergo several stages of reconstructive heart surgery. They may also require lifelong follow-up care.

Mrs. Ciccone says that she and her doctor were unaware of the risk of Zoloft birth defects. She alleges that Pfizer should have known about the studies linking Zoloft to birth defects. Before 2002, there was a 1996 study published in the New England Journal of Medicine linking the maternal use of SSRIs to an increased risk of a lung defect called Persistent Pulmonary Hypertension of the Newborn (PPHN), low birth weight, premature birth, and more. Animal studies Pfizer conducted before Zoloft’s approval indicated that the medication could cause cranio-facial defects (such as cleft lip) and other physical defects, including clubfoot.

Since these early studies were published, researchers have continued to publish studies linking SSRIs (including Zoloft) to many severe birth defects. Zoloft has been specifically linked to increased risks of septal heart defects, abdominal defects (omphalocele), cranial defects (craniosynostosis, anencephaly), and more.

Despite the fact that more than a dozen studies have linked SSRIs to birth defects, and the FDA requires drug companies to update the warnings on medications whenever a possible risk is discovered, Pfizer still defends the safety of using Zoloft during pregnancy. The labels still do not warn about the risk of heart defects and other birth defects. According to the Ciccones’ Zoloft lawsuit, “Even in the face of numerous published studies, Pfizer continues to deny these dangers and will not revise its drug labeling.”

The Ciccones are now seeking justice and financial compensation for Noelle’s birth defects. Their Zoloft lawsuit seeks damages for her pain and suffering, mental anguish, embarrassment, humiliation, disfigurement, decreased quality of life, and more.

The Ciccones will join nearly 150 other Zoloft lawsuits pending against Pfizer in federal court. These lawsuits were recently centralized in a Multidistrict Litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania, before Judge Cynthia M. Rufe. The MDL continues to grow at a rapid pace as more families file lawsuits against Pfizer.


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