Over 200 Families Have Filed Zofran Lawsuits

author by Jasper Dudley Ward on Sep. 30, 2016

Health Care Pharmaceutical Product Health Care  Medical Products & Devices Lawsuit & Dispute  Class Action 

Summary: As of February 16, 2016, 224 Zofran lawsuits have been consolidated in the U.S. District Court for Massachusetts. Each of these complaints accuses GlaxoSmithKline, the makers of Zofran, of promoting their drug for non-FDA approved uses and of concealing evidence of Zofran’s link to birth defects.

As of February 16, 2016, 224 Zofran lawsuits have been consolidated in the U.S. District Court for Massachusetts. Each of these complaints accuses GlaxoSmithKline, the makers of Zofran, of promoting their drug for non-FDA approved uses and of concealing evidence of Zofran’s link to birth defects.

Families File Zofran Lawsuits for Heart Defects

The majority of these lawsuits have been filed by the families of babies born with heart defects, such as atrial septal defect, ventricular septal defect and atrioventricular septal defect. The parents of these babies cite numerous studies which link Zofran with congenital heart defects. In one study, for example, mothers taking Zofran in the first trimester of pregnancy were shown to be 200% to 400% more likely to deliver babies born with heart problems.

In another study conducted by Danish researchers in 2013, Zofran showed a strong link to a variety of congenital heart defects. Looking at 900,000 birth records from the Danish Medical Birth Registry, including 1,368 women who took Zofran in the first trimester, researchers came to shocking conclusions. Mothers taking Zofran in the first trimester had:

  • A 30% increased risk of congenital malformations
  • 6 times the risk of heart defects
  • 1 times the risk of atrial septal defects
  • 3 times the risk of ventricular septal defects
  • 8 times the risk of atrioventricular septal defect

GlaxoSmithKline’s Off-Label Marketing

GlaxoSmithKline (GSK) advertised Zofran as a “safe” and “effective” treatment for pregnant women suffering from morning sickness. What doctors and patients didn’t know, however, was that Zofran was never approved by the FDA for use by pregnant women. Currently, the FDA has only approved Zofran for the treatment of nausea and vomiting in chemotherapy and surgery patients. This is because there have been no human clinical trials testing the safety of Zofran in pregnant women.

In 2012, as a result of their illegal marketing practices, GSK was forced to pay $3 billion to the U.S. Department of Justice. None of this money, however, went to the victims of Zofran birth defects.

Contact a Zofran Lawyer

 If you or someone you know took Zofran while pregnant and had a baby born with birth defects, you should take action. GlaxoSmithKline have been negligent and misleading in their actions, disregarding public health and safety in the process. You should seek justice, not just for yourself, but also for other women who are still not aware of the potential risks. Fill out our online form and receive a free case evaluation or call us at 888-595-2922.

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