A woman alleges her daughter, born in 2007, is a victim of her having taken Zofran during her first trimester of pregnancy. The anti-nausea drug is a treatment for chemotherapy patients, radiation patients, and patients’ recovering from the effects of surgical anesthesia. Zofran had never been approved for use in pregnancy.
The New Jersey woman claims her daughter, now nine years old, was born with both atrial and ventricular septal defects, called “hole in the heart” abnormalities. These abnormalities occur is when the barriers in the heart fail to close properly. The daughter was also born with a low birth weight and struggles with developmental delays requiring special education services.
The child’s hydronephrosis, a kidney condition, along with countless facial abnormalities are also included in the mother’s complaint. The child was born with a high palate, recessed chin, small jaw, and low set ears. She also has a condition since birth in which pinky fingers are bent inward from the topmost knuckle, called clinodactyly.
Birth defects are not a part of the mother’s family history and genetic testing failed to detect otherwise. However, new studies have linked Zofran to major birth defects such as “hole in the heart” and cleft palate. In 2013, Denmark researchers found that unborn children exposed to Zofran are between two and four times more likely to be born with cardiac septal defects.
GlaxoSmithKline, the pharmaceutical company behind Zofran, is being sued by close to 300 families over birth defects they believe were caused by prenatal exposure to the anti-nausea drug. The New Jersey mother’s lawsuit was originally filed in the U.S. District Court of New Jersey on March 15, 2016. It has now been transferred to the Boston court where over 270 Zofran lawsuits have been consolidated. August 1, 2016 is the most recent filing representing an amended complaint in the U.S. District Court of Massachusetts.