Things are heating up this week. World leaders are talking about climate change in Paris. And on the pharmaceutical litigation front, GlaxoSmithKline is feeling the heat from hundreds of Zofran birth defect lawsuits.
The Daily Beast took on Zofran birth defects in a November 2015 article. They focused on Deana Brown, a mother who took Zofran, a drug manufactured by GlaxoSmithKline (GSK), during her pregnancy. Now, Brown is the plaintiff in a lawsuit targeting GSK over her child’s Zofran birth defects.
Brown’s child was born with “amniotic band constriction and a teratologic clubfoot deformity”.
Zofran isn’t FDA-approved to treat morning sickness. However, doctors write off-label prescriptions for pregnant women.
Doctors can recommend the off-label use of a drug, but the drug’s manufacturer isn’t allowed to promote that drug for any use other than those with FDA approval. Still, GSK launched a marketing campaign to promote Zofran as safe for pregnant mothers.
This move resulted in civil and criminal charges.
As a result of their illegal promotion, GSK paid $3 billion to settle charges brought by the US Department of Justice.
In August 2015, the American College of Obstetricians and Gynecologists (ACOG) released new information on morning sickness treatments. According to The Daily Beast, the organization noted that more research is needed to determine the safety of Zofran use during pregnancy.
The Daily Beast reached out to GSK for comment. They responded, and stated that the Zofran lawsuits are “unfounded”.
The Daily Beast also reached out to Brown’s legal representative, who said that GSK could’ve conducted Zofran clinical trials, but they “just chose not to”.
Was your child born with Zofran birth defects?
We encourage you to explore your legal options and compensation eligibility. Our law firm offers free case consultations. Share your Zofran story with one of our Zofran lawyers today.
Call Carey Danis & Lowe toll free at 1-800-721-2519. You can also reach us online by completing a confidential personal injury form.
References: Pharmaceutical litigation, Zofran