New Lawsuits against GlaxoSmithKline over Zofran (ondansetron)

New lawsuits have been filed against GlaxoSmithKline (GSK), the pharmaceutical company that manufactures Zofran (ondansetron). The latest lawsuit in the pending multidistrict litigation (MDL) comes from parents in Texas who are saying they were deceived into believing Zofran was safe for use during pregnancy.

Unfortunately for the parents, their first daughter died in 2000 after being born with a malformed aorta and a heart that was only 1/5th the size it should have been. Their second daughter was also born just 3 years later with birth defects, including severe vomiting and reflux issues. Their second daughter also had to endure an extended stay in the hospital and was later diagnosed with both kidney and urinary tract defects.

The mother had been prescribed Zofran during both pregnancies, and the drug was supposed to help her with her morning sickness. The parents in the lawsuit are actually not blaming their doctor for prescribing Zofran to the mother, but rather GSK, stating that the parents as well as the doctor relied on statements made by GSK before prescribing the mother Zofran.

Though Zofran has been used to treat morning sickness in pregnant women, it was never approved by the FDA for such a use. Originally, when Zofran was approved by the FDA in 1991, it was approved to prevent nausea or vomiting in patients that have recently undergone surgery, radiation, or chemotherapy. Using Zofran off-label for the treatment of morning sickness is legal, but many studies have shown that mothers who take Zofran during pregnancy are more likely to have babies born with congenital defects.

A Danish study found an overall 30% increase in risks for major congenital malformations in patients who took Zofran during pregnancy. A recent study of over 90,000 Australian pregnancies by BioMed Research International also found an increase in the risks for major birth defects, preterm births, shorter birth length, and maternal urinary tract infections in those who took Zofran during pregnancy.

Currently, there are more than 200 lawsuits filed against GSK that have been consolidated in an MDL in the U.S. District Court for the District of Massachusetts under Honorable F. Dennis Saylor, IV. The purpose of consolidating the lawsuits is to allow for easier pretrial proceedings.

The first cases to go to trial will be the bellwether trials, but there is no date set for the first trial at this point in time.