Zofran Birth Defects: McIntyre Law is on your side!

Noble McIntyre on July 21, 2015


baby bentrup Photo Source

If you’re a mom, chances are you would never consider doing anything that could possibly harm your child – but what if you were prescribed a medication during your pregnancy that did exactly that… and you didn’t know the risks?! That’s what has happened to women who are now lining up to file lawsuits against manufacturer GlaxoSmithKline because the company marketed Zofran (generic name: Ondansetron) as a drug that would ease morning sickness nausea, but the FDA had not approved it for that purpose.

A doctor could prescribe an “off-label treatment” to a patient, which means that the treatment or medication is FDA approved, but not for the purpose for which the doctor is prescribing it in that case. Zofran has been used successfully for many years to treat nausea caused by chemotherapy and after surgeries. But, it has not been approved to treat nausea in pregnant women. The lawsuits allege that the drug causes severe birth defects for the unborn babies, and could even cause the pregnancy to terminate, or miscarry.

Woman forced to terminate pregnancy because of Zofran defects

Just three months ago, a Massachusetts woman filed suit against GSK, claiming that following her having been prescribed Zofran as an off-label treatment for morning sickness, she learned that her unborn baby had developed life-threatening abdominal defects that forced her to terminate the pregnancy.

This plaintiff claims that GSK promoted the use of Zofran as being safe and effective to treat morning sickness, but that it violated federal law by doing so because it had not been approved by the FDA for that purpose. These are the same allegations that surfaced against GSK back in 2012, when the first Zofran lawsuits were filed.

Did GlaxoSmithKline conceal evidence of the risks of Zofran?

Families and survivors say that the manufacturer failed to disclose evidence to the FDA that would show that Zofran had risks to unborn children. There have been subsequent studies that shows association between prenatal Zofran use and increased risk of congenital heart defects and cleft palates. These plaintiffs have said that GSK knew about birth defects from Zofran as far back as 1992, but that the company did not share that information with pregnant women or their physicians. The Massachusetts plaintiff has said that if she knew that Zofran was associated with birth defects, she would not have taken the drug. She further claims that had she not taken the drug, she would have given birth to a healthy child rather than having been forced to terminate the pregnancy.

Zofran lawsuit update

On July 6, 2015, GSK requested that the court consolidate its Zofran birth defect lawsuits so that all of the cases are combined into a single set of motions and discovery. Currently, there are 12 Zofran lawsuits before U.S. courts. Each case involves Zofran birth defects allegedly caused after the drug was prescribed to a pregnant woman to ease nausea and vomiting associated with morning sickness. Defects include:

  • cleft lip
  • cleft palate
  • holes in the heart (atrial and ventricular septal defects)

If you’ve been injured by Zofran, here’s what to do

If you or your baby have been injured as a result of having taken Zofran during pregnancy, contact McIntyre Law today. Our experienced Zofran attorneys are working on litigation to help plaintiffs get the compensation they deserve. You don’t have to let the Big Pharma drug companies get away with making millions (or billions) at your expense. If you took a drug that damaged you or your baby because you were given inaccurate information (or too little information), we can help. Contact us for a free consultation.

McIntyre Law also handles cases for injuries from several other drugs, including Paxil, Levaquin, Xarelto and others. You don’t have to suffer alone. We’re here to help with any of your drug liability needs.


Noble McIntyre

Noble McIntyre is the senior partner and owner of McIntyre Law who focuses primarily on drug litigation and catastrophic injury cases. He is currently representing clients injured by the drugs Paxil, Levaquin and testosterone therapy drugs and by clients affected by oil field injuries. His goal has and continues to be to work diligently on behalf of his clients to achieve the highest and best result for his clients’ injuries while maintaining professionalism and abiding by all ethical standards of his profession. Read more about Noble McIntyre.


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