April 6, 2015 — A lawsuit has been filed by a mother in Alabama who had a child with serious birth defects after using Zofran for morning sickness during the first trimester of pregnancy.
The lawsuit (PDF) was filed in federal court in Alabama. The plaintiff was prescribed Zofran in January 2006 to prevent nausea during her pregnancy. Eight months later, she gave birth to a boy named Talon with several birth defects.
Shortly after Talon was born, he was diagnosed with a distended kidney and a ureteral disorder. When he was approximately nine months old, he suffered his first seizure and was diagnosed with a seizure disorder.
Now 8 years old, Talon is a special needs child who is non-verbal, has delayed reactions, glaucoma, extra digits on his hands, a high narrow pallet, and was eventually diagnosed with a chromosomal defect. Genetic testing of Talon’s parents have found no chromosomal issues that could be congenitally passed to the boy.
The lawsuit accuses GlaxoSmithKline (GSK), the manufacturer of Zofran, of negligence for failing to warn about side effects. Furthermore, the lawsuit claims Zofran was “defective and unreasonably dangerous” when used by pregnant women, and GSK knew or should have known about this risk.
In 2012, the Justice Department and GSK reached a $3 billion settlement for improperly marketing several drugs, including Zofran in pregnant women. Zofran is not approved or recommended for pregnant women, but it is used “off-label” by about 1 million pregnant women per year for morning sickness.
Several case reports and studies have suggested that Zofran might increase the risk of birth defects, including cleft palate, kidney defects, and heart defects. Despite these studies, GSK has failed to update the warning label on Zofran or conduct comprehensive studies to investigate the risk.