Currently, GlaxoSmithKline (GSK), the makers of the popular anti-nausea medication, Zofran, is facing more than 30 Zofran lawsuits from parents who had children with birth defects, a number that is expected to grow.
Zofran is Not Intended for Pregnancy
The U.S. Food and Drug Administration (FDA) approved Zofran for use by cancer patients and surgery patients experiencing nausea and vomiting. It has never been approved for pregnant women to use, yet GlaxoSmithKline began marketing Zofran to help treat morning sickness. Reports suggest that the company also offered kickbacks to physicians who prescribed the medication to women experiencing morning sickness.
Consequently, pregnant women who took Zofran began having babies born with various types of birth defects, including clubfoot, heart malformations, lung disorders, cleft lip, cleft palate, and more.
Studies on Zofran
Shortly after, numerous studies regarding taking Zofran while pregnant began to happen across the world. Most studies show a high increase of infants developing certain birth defects if their mothers took the medication while pregnant. The research includes:
- Between 1997-2010, scientists in Denmark studied over 900,000 women who took Zofran while pregnant. Results indicate a heightened risk of birth defects associated with Zofran.
- In 2012, the National Institutes of Health (NIH) published a study that indicates infants who are exposed to the medication during the first trimester are twice as likely to develop cleft lip and cleft palate.
- In a 2013 study, published by BioMed Research International, results show that there is a 20% increased risk of birth defects with infants exposed to Zofran as well as a heightened risk of premature birth.
- A 2014 study published by NIH shows that infants exposed to Zofran while in utero are twice as likely to develop a hole in the heart.
In addition, GSK performed its own Zofran, primarily on animals, which showed that the drug can cause an increase in birth defect risks if taken while pregnant. Yet, according to the majority of lawsuits filed against the company, GSK failed to warn the public and provide the results of the studies.
Why GSK is Facing Zofran Lawsuits
According to a Zofran attorney who specializes in dangerous pharmaceutical drug cases, GSK is promoting a medication for morning sickness that was never approved for that specific use.
“If they’re marketing and pushing a drug for a certain indication, and don’t have FDA approval for that indication, that’s a problem for GSK in and of itself.”
However, GSK, in its defense, is claiming that animal studies are not always indicative of how humans will react to medications.
“Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.”
Yet, if GSK says that animal studies aren’t the same as human studies, many people are wondering why the medication was ever prescribed to pregnant women in the first place, without the proper studies done beforehand. GSK has declined to comment on the issue, but with more and more cases building up against the company, additional studies are being conducted to help prove how much damage Zofran can do to a developing fetus.
Lawsuits Filed Across the Nation
Zofran lawsuits have already been filed in around 15 states across the nation, and this number is expected to grow significantly in the future. It’s important to note that if you were prescribed Zofran while pregnant and in turn, your baby was born with birth defects, you have the same legal right as the other plaintiffs to file a lawsuit against the responsible party.
GSK is known for misrepresenting its medications, as seen in a $3 billion settlement case against the company for false claims about their antidepressant medications. For additional information on GSK lawsuits, visit our article, GlaxoSmithKline Lawsuits.