Doctors have prescribed Zofran to pregnant women who wanted a medication that would treat nausea and vomiting during their pregnancies. The US FDA (Food and Drug Administration) has given its approval to Zofran. According to the FDA, the drug can be taken to help patients suffering from cancer and it is also okay to take the drug for nausea after a treatment or surgery.
The drug Zofran has helped patients who used to vomit from the side effects of chemotherapy. It has also helped those who felt sick after consuming post-operation medications to help deal with pain as well as other complications.
All would have been well had not the makers of Zofran (GlaxoSmithKline) not found new patients to take their drug. The company began to offer Zofran to pregnant women who suffered from morning sickness. The only problem with this was that Zofran did not have the FDA’s approval to prescribe the drug to pregnant women.
When the company was sued, it pleaded guilty of fraud and for illegally promoting a variety of drugs, of which Zofran was one. GlaxoSmithKline was forced to pay three billion dollars in a legal settlement. Now, the same company has again been taken to court to defend against concrete allegations about the use of its drug, Zofran. So, why is the company being sued left right and center?
According to court documents, it is clear that GlaxoSmithKline knew way back in the year 1992 that their drug Zofran would prove to be dangerous if taken by pregnant women. Since the drug travels through the placenta, it can harm the condition of the unborn baby. The company chose to ignore this information and continued to market Zofran as a drug that could treat pregnant women suffering from morning sickness.
Most lawsuits dealing with this issue claim that GlaxoSmithKline was duty-bound to ensure that Zofran be safe to use before offering it to the public. What’s more, the company had also failed to find out the safety risks before vending it to the public. The lawsuits also claimed that GlaxoSmithKline did not warn the public about the potentially dangerous side effects of Zofran. Thirdly, the lawsuits also claimed that GlaxoSmithKline had advertised Zofran as a safe drug to treat morning sickness and hyperemesis gravidarum, even though the FDA had not approved it. Fourth, the company had misrepresented itself and fooled the public into believing that the drug was in fact safe to use, when animal studies showed that the drug could cause abnormal growth of bone and toxicity. GlaxoSmithKline was also accused of not evaluating available data and safety information properly. Some lawsuits also claimed that GlaxoSmithKline had produced a drug that was defective and that the company had fraudulently made claims that Zofran was safe for pregnant women.
The truth is that Zofran has never been given approval by the FDA for use in pregnant women. The lawsuits filed against the company also accused it of selling the drug to pregnant mothers and paying doctors to prescribe Zofran to expectant mothers. In doing so, GlaxoSmithKline earned many millions of dollars, as approximately one million women had taken the drug every year.
Pregnant women who had consumed Zofran and whose children were born with birth defects are entitled to sue the company. The truth is that approximately 80 percent of pregnant women suffer from some sort of nausea or vomiting during their pregnancy. This condition is normally referred to as morning sickness. The most serious form of this condition is known as hyperemesis gravidarum. Hyperemesis gravidarum leads to problems like malnutrition and it can endanger the lives of both mother and the yet-to-be-born baby.
Many women took Zofran in the belief that this drug would keep them and their babies safe. They were shocked to find that their babies were born with grave birth defects that would make them totally dependent on their mothers and fathers for care. These birth defects include heart defects, cleft lip and cleft palate.
Most lawsuits related to the use of Zofran by pregnant mothers claim that GlaxoSmithKline was liable for the injuries caused to the babies whose mothers took Zofran during their pregnancies.