Zofran use during pregnancy has been linked to various birth defects. Families of babies who were born with birth defects after their mothers took Zofran during pregnancy are filing lawsuits against GlaxoSmithKline and doctors who prescribed the drug. Families have filed a product liability lawsuit against the company that made the drug. They may also be able to sue the doctor who prescribed an off-label medication.
Zofran Is Prescribed for an Off-Label Purpose
Zofran is a medication that has been prescribed to prevent morning sickness in pregnant women. However, that was not the drug’s primary purpose. While Zofran’s purpose was to prevent nausea, it was approved to treat cancer patients who were undergoing chemotherapy. Zofran was never approved by the FDA to treat pregnant women. Instead, the manufacturer encouraged this usage on its own, and doctors went along and prescribed it.
Zofran impacts far more than the mother. The drug is passed to the baby through the placenta. This could cause a number of birth defects that may include:
- Hearing loss
- Skull deformities
- Rapid heartbeat
- Cleft palate
These birth defects may impose suffering for the baby and substantial costs on the family over the course of the child’s lifetime.
GlaxoSmithKline has already paid a heavy price for promoting Zofran’s off-label usage without FDA approval. The company was fined $3 billion and pled guilty to fraud. However, this does not help families who are dealing with the costs of their child’s birth defects.
Medical Malpractice Lawsuits May Still Be Possible
A federal judge just made it much harder to sue GlaxoSmithKline, dismissing the multidistrict lawsuit against the company on the basis of preemption. However, families with babies who have suffered birth defects from Zofran could still file a medical malpractice lawsuit against the doctor who prescribed the drug. After all, doctors have known of possible complications for babies from this drug for years, yet they continue to prescribe the drug. Doctors could be liable for injuries after prescribing an off-label medication.
Although the FDA did not adjust the warning label for the product even knowing the possibility of birth defects, doctors should still refrain from prescribing the drug due to the decades of evidence about the danger. A medical malpractice lawyer can help families determine whether they have grounds to file a medical malpractice claim or lawsuit.