Two mothers – one residing in Minnesota and another from Massachusetts – both filed a product liability lawsuit in the past week against GlaxoSmithKline. They both raised almost the same allegations against Zofran, the drug which they used during their pregnancies. They both claimed that the product caused their babies to be born with serious birth defects. Zofran is a prescription drug that has been approved and used to prevent vomiting and nausea, especially amongst chemotherapy patients. It is widely recommended by some medical experts to be used by pregnant women to treat morning sickness, despite the fact that the FDA has not established it to be either safe nor effective.
As per the allegations that were raised by the two mothers concerning Zofran birth defects, GlaxoSmithKline illegally distributed the drug, claiming that it was a safe remedy for morning sickness. That is why most pregnant women opted to use the product, especially those who were suffering from morning sickness. However, the company failed to warn the community about the dangers of using the drug, especially during the first trimester of the pregnancy. They also failed to reveal the possible risks of congenital malformations, which include cleft palate, heart defects and cleft lip, as well as other disorders that may result from the use of this product.
A complaint filed against one of the mothers by GlaxoSmithKline on February 12 in U.S. District Court (Eastern District of Pennsylvania) indicated that her two children, one of them born in 2004 and the other in 2006, suffered the congenital heart abnormality after the exposure to Zofran when she was pregnant.
On February 16, another PDF complaint was filed in U.S. District Court (District of Massachusetts). Tomesha LeClair claimed that after being exposed to Zofran during her first trimester of the pregnancy, her daughter had heart defects and other congenital defects. Her child had undergone several surgeries (more than three) and she continues suffering from the serious developmental delays and some other associated health problems that resulted from the use of Zofran.
As per the lawsuits, GlaxoSmithKline was aware of the potential link between Zofran and birth defects. According to the complaints, GlaxoSmithKline performed a series of studies in the mid-1980s that showed that the product interfered with the placenta in rabbits and rats during pregnancy.
Even though the company had performed studies that revealed toxicity, intrauterine fetal deaths, incomplete bone growth and premature births, it declared that Zofran had no adverse effects to fetuses.
The company started receiving the reports about the birth defects in 2000, including 32 reports about expectant mothers who used this product. Those babies who did not die outright during delivery were being born with dysmorphism, kidney defects, congenital heart disease, skeleton and bone problems and other associated birth defects.
The lawsuit noted that in most cases, GlaxoSmithKline had received a lot of reports on a monthly basis, weekly basis and even on a daily basis. On September 13, 2000, GlaxoSmithKline got three different reports which involved the use of Zofran and its negative side effects. Two of those reports showed that the babies died due to the adverse effects of the product.
GlaxoSmithKline knowingly promoted the consumption of the product as a remedy for morning sickness among pregnant women despite knowing the pregnancy risks that are associated with the product. The main aim of doing this was to take advantage of its demand by pregnant women who suffer from morning sickness during the first trimester of pregnancy. It was all about profit, regardless of who got hurt. GlaxoSmithKline agreed to pay three billion dollars to settle the civil and then the federal criminal charges in 2012. Charges stemmed from the illegal promotion and marketing of the drugs, which included the marketing and the promotion of Zofran for the pregnant women.
It is the expectation of everyone that in the months and years to come and as more people and families learn the adverse effects of the drugs, especially on the unborn babies, there will be more lawsuits against Zofran on behalf of children all over the United States.