June 16, 2015 — Two women have filed a lawsuit against GlaxoSmithKline (GSK) in Louisiana federal court after they used Zofran as an off-label morning sickness treatment and had babies with birth defects.
The lawsuit (PDF) was filed on June 8 in the U.S. District Court for the Western District of Louisiana, Case No. 6:15-cv-01815.
One plaintiff, Stacy Coughlin, started taking Zofran in January 2010, during her first trimester of pregnancy with a child named in the lawsuit as “L.D.” The baby was born in July 2010 with a number of heart defects, including ventricular septal defect (VSD), which required surgery to correct, atrial septal defect (ASD), and intermittent tachypnea, which is reflective of congestive heart failure.
The other plaintiff, Ashley Swann, started taking Zofran in February 2005, during her first trimester of pregnancy with “V.P.” The baby was born in August 2005 ventricular arrhythmia, a serious heart defect that nearly caused the child’s death shortly after birth. For the first five years of her life, she required regular medical monitoring and testing.
GSK is accuse of negligence for many reasons, including advertising Zofran to pregnant women for morning sickness without adequately testing it for that purpose. GSK is also accuse of failing to warn about the dangers associated with using Zofran during pregnancy.
Unfortunately, several studies published in the last few years have found evidence that Zofran increases the risk of heart defects. One study published last year in Reproductive Toxicology found a doubled increased risk of “hole in the heart” defects. Another study involving 900,000 pregnancies in Denmark also found that Zofran doubled the risk of having a baby with heart defects, leading to a 30% increased risk of birth defects overall.