Dangerous Drugs & Devices

What Is Zofran?

Zofran, a drug developed by GlaxoSmithKline, was approved by the Federal Drug Administration (FDA) to prevent nausea and vomiting secondary to radiation therapy and chemotherapy. The drug has been in use since 1991 and has proven very effective in preventing nausea.

Zofran has never been approved for any other use; the FDA never approved Zofran to treat pregnancy-related morning sickness. Despite this, GlaxoSmithKline actively encouraged family doctors and obstetricians to prescribe Zofran to pregnant women. There is an obvious difference between the medical risks deemed acceptable for a cancer patient fighting to survive and those of a baby developing in the womb.

Finally, in 2012, GlaxoSmithKline pleaded guilty to promoting Zofran for non-approved uses and to paying kickbacks to prescribing physicians. The company paid $3 billion to resolve these civil and criminal charges.

Despite the financial penalty, the damage is done: thousands of children have been harmed by GlaxoSmithKline’s illegal actions. In addition, lots of doctors are so accustomed to using Zofran for morning sickness that they are still prescribing it.

What are the Potential Injuries?

There are few risks to the adult patient when the drug is taken as approved by the FDA. However, when Zofran is taken for morning sickness, the risk of birth defects increases because the drug passes through the placenta into the growing baby. Babies affected by Zofran can be born with a long list of serious health problems including:

  • A cleft palate
  • A cleft lip
  • Kidney malformations
  • Heart defects
  • Organs on the outside of the body cavity
  • Severe brain defects
  • Musculoskeletal abnormalities

In addition, pregnant women who take Zofran may suffer from abnormal, and potentially fatal, heart rhythms.

What is the Legal Status?

Lawsuits are being filed by women who took Zofran while pregnant and gave birth to children with a defect. Compensation is being sought for medical expenses, emotional suffering, loss of enjoyment of life due to disability and loss of future income potential.

These claims are being filed throughout the country and we expect that a Multi-District Litigation will be created. That means that a single judge will oversee all of the individual claims. Each claim will still be an individual case; however, it will be standing side-by-side with those of other women and children who also suffered from Zofran-related birth defects.

If you took Zofran while pregnant and your child was born with a defect, contact Oxner + Permar for a free consultation.