Zofran Birth Defects Lawsuits: Just the Cost of Doing Business for GlaxoSmithKline?

February 25, 2015, 1:30PM. By Jane Mundy

Boston, MATwo product liability lawsuits have now been filed against GlaxoSmithKline (GSK), the maker of Zofran, claiming the drug used during pregnancy caused their children to be born with birth defects.

Despite studies that have linked Zofran to birth defects, the drugmaker chose to market its drug off-label to pregnant women to treat morning sickness. Zofran is only approved by the FDA for use by patients undergoing surgery or cancer treatments.

Zofran lawsuits

Court records show that two Zofran lawsuits have been filed this month claiming that the drug caused children to be born with serious heart problems. A mother from Minnesota filed a lawsuit claiming she used Zofran during her pregnancies in 2004 and in 2006. Both Cheri Flynn’s children were born with serious heart defects (Case 2:15-cv-00709-PD).

Another lawsuit was filed in the U.S. District Court, District of Massachusetts, claiming a child was born with several congenital heart abnormalities. Tomesha LeClair took Zofran during her first trimester of pregnancy. LeClair’s child has undergone at least 13 different surgeries and continues to suffer from developmental delays and other health problems, according to the lawsuit, which also claims that GSK failed to warn her and her physician of this risk (Case 1:15-cv-10429).

Further, the world’s sixth-largest pharmaceutical company has been accused of bribing doctors with money and gifts to prescribe Zofran, a practice that appears to be commonplace with GSK - the number-one big pharma repeat offender. GSK since 1991 has paid a whopping $7.56 billion in criminal and civil penalties, according to Sidney M. Wolfe at Public Citizen. GSK has done its math and the cost of penalties, now likely to include Zofran birth defects lawsuits, is simply the cost of doing business.

In 2012, GSK agreed to pay $3 billion to settle a number of allegations including illegally marketing Zofran for non-approved use - but the company’s profits in that year alone were $7.7 billion.

Zofran studies

In 2014, a study that used data from the Swedish Medical Birth Register, titled “Use of Ondanesetron [Zofran] During Pregnancy and Congenital Malformations in the Infant,” showed that using Zofran during the first trimester more than doubled the risk of the child developing a cleft palate, and the “risks for a cardiovascular defect and notably a cardiac septum defect were increased and statistically significant.”

In 2012, The Center for Birth Defects Research and Prevention published a study suggesting that women who used Zofran during the first trimester of pregnancy had a twofold increased risk of having a child with birth defects.

Although Zofran was not approved by the FDA for morning sickness, and despite studies linking the drug to birth defects, GSK continued to promote the use of its drug off-label.