A woman from New Jersey filed a lawsuit against the manufacturer of Zofran, GlaxoSmithKline, alleging the company failed to warn her of the risk of birth defects associated with taking the drug during pregnancy.
The woman suffered from migraines and morning sickness in her first trimester, and was prescribed the anti-nausea medication Zofran to treat her symptoms. The woman believes exposing her child to Zofran in utero caused her child to suffer several debilitating birth defects.
The woman’s child was born with atrial and ventricular septal defects. These defects occur when the barriers in the heart fail to close properly, leaving a hole. The child also suffers from hydronephrosis, a condition characterized by excess fluid in one or more of the kidneys due to a back up in urine, and clinodactyly, a condition in which the pinky fingers are bent inward from the topmost knuckle.
The child also has several facial deformities including a high palate, recessed chin, small jaw, and low set ears. The New Jersey woman claims her child is continually suffering from developmental delays, requiring specialized education services.
Searching for answers, the mother turned to genetic testing to try to detect a genetic anomaly that would be responsible for her child’s birth defects. However, the child does not appear to have any genetic abnormalities that would cause birth defects.
In 2013, a study found that babies exposed to Zofran in utero were between two and four times more likely to develop birth defects. The New Jersey woman now joins 300 other families whose children have suffered birth defects from Zofran as they sue GSK for damages.
The families believe GlaxoSmithKline illegally marketed Zofran to pregnant women for treating morning sickness even though the FDA did not approve it for that use. Plaintiffs are pointing to a settlement in 2012 in which GlaxoSmithKline agreed to pay $3 billion to the U.S. Department of Justice to resolve fraud allegations and failure to report safety data.
The discovery process is underway, and plaintiffs eagerly await their day in court. GlaxoSmithKline is fiercely fighting the allegations, but plaintiffs won’t let them out without a fight.