Legal action against GlaxoSmithKline (GSK), makers of the anti-nausea drug Zofran continues to build, as more women allege their use of the drug during pregnancy resulted in their babies being born with severe birth defects.
Further research is needed to prove a direct link between Zofran use and birth defects, but many women believe the link is a foregone conclusion – and doctors are playing it safe. In an interview with The Daily Beast, OB/GYN Dr. Amy Tuteur noted Zofran can help some women dramatically, but it should always be used a last resort, “… reserved for those who really need it…”
Doctors are concerned that making broad statements concerning the dangers of anti-nausea drugs during pregnancy could cause drug manufacturers to shy away from research and development of these types of drugs, something many doctors believe would be a mistake and make it especially difficult for women who have few choices in treating severe morning sickness.
Zofran's potential risks have also caught the attention of the American College of Obstetricians and Gynecologists. The organization recently updated its morning sickness guidelines and stated that further research was needed concerning the drug and there is no definitive link as of yet. Zofran is a Category B pregnancy drug according to the Food and Drug Administration (FDA), which means its' safety has been studied in animals but not humans. Because of this there is no definitive information on the drug's ability to cause birth defects, but the organization agrees it should be used only when absolutely necessary during pregnancy.
Legal Action against GSK
Despite the lack of definitive evidence, there are those who believed without doubt their use of Zofran during pregnancy was responsible for their child's birth defect, and there are several lawsuits alleging GSK of concealing the known risk of harm. Deanna Brown, represented by Andrus Wagstaff PC, claims had she known of any risk associated with the drug she would have not used it during pregnancy.
She is not alone. Nearly 200 Zofran-related lawsuits have been filed in US courts and many are in the process of being consolidated into multidistrict litigation in Massachusetts.
According to attorney Aimee Wagstaff, part of Brown's legal team, GSK had evidence from its own animal studies of “several concerning trends related to fertility and fetal development” tied to the use of Zofran but continued to “launch and market” the drug anyway.
Wagstaff goes on to point out that if the company were really concerned about providing an option for treating morning sickness, it would have studied “…the effects of its own drug on pregnant women rather than subjecting unborn children and their families to unknown and untested side effects.” Wagstaff further points out the company has the resources needed to conduct such a clinical trial.
GSK Named in Previous Lawsuits
This is not the first time GSK has faced legal trouble. In 2012, GSK was accused of “knowingly [promoting] the sale and use of Zofran for a variety of conditions other than those for which it was approved as safe and effective by the FDA…” The company plead guilty to other charges and paid $3 billion in criminal and civil liability because of unlawful promotion of prescription drugs.
For more information on the Zofran lawsuits against GSK or to read the entire article in which Wagstaff was quoted, visit The Daily Beast and Courthouse News Service.