September 5, 2012 — A new Zoloft birth defect lawsuit has been filed by Denise and Nicholas Ciccone, the parents of Noelle M. Ciccone, a child who was born in 2002 with clubfoot, truncus arteriosus, and other related conditions after her mother took Zoloft (sertraline) during pregnancy.
According to the complaint, “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, a condition in which the foot is turned inward and downward at a sharp angle at the ankle joint. It severely impairs walking ability. She also suffers from truncus arteriosus, a condition in which one single blood vessel is attached to the right and left side of the heart, instead of two vessels (the aorta and pulmonary artery). Babies with truncus arteriosus often require multiple heart surgeries and ongoing care.
Before Mrs. Ciccone used Zoloft during pregnancy, there was evidence that Zoloft could increase the risk of congenital birth defects. A study published in the New England Journal of Medicine in 1996 by Christina Chambers found that infants exposed to an SSRI antidepressant late in pregnancy were more likely to have Persistent Pulmonary Hypertension of the Newborn (PPHN), premature birth, low birth weight, and other disorders.
Before the FDA approved Zoloft, animal studies indicated that the medication could cause birth defects, including cranio-facial malformations (cleft lip) and limb defects such as clubfoot.
After these early studies pointed to a possible link between SSRIs and birth defects, researchers have published more studies confirming these findings. Studies have linked Zoloft to birth defects such as anencephaly, craniosynostosis, omphalocele, septal heart defects, intellectual disabilities, and more.
Although FDA regulations require drug companies to update the warnings on medications when there is evidence of a side effect, Mrs. Ciccone alleges that Pfizer failed to adequately warn doctors and the public about the serious risks of using Zoloft during pregnancy. The current label on Zoloft still does not warn about the increased risk of heart defects and other birth defects that have been associated with Zoloft. According to the Ciccones, “Even in the face of numerous published studies, Pfizer continues to deny these dangers and will not revise its drug labeling.”
The Ciccones are seeking compensation for their child’s pain and suffering, mental anguish, embarrassment and humiliation, disfigurement, and decreased quality of life due to her congenital birth defects.
Nearly 150 Zoloft lawsuits throughout the United States have been centralized into the Zoloft Multidistrict Litigation (MDL) in the U.S. District Court for the Eastern District of Pennsylvania before Judge Cynthia M. Rufe. It is likely that the Ciccones’ Zoloft birth defect lawsuit will also be transferred to that court for pre-trial proceedings.