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zofran-baby-nicuA California couple has filed a lawsuit alleging the anti-nausea medication Zofran caused life-threatening birth defects of their child.

The San Francisco parents state in the Zofran birth defect lawsuit that their child was born in 2009 with a heart defect known as bicuspid aortic stenosis which requires extensive medical monitoring and surgeries to repair.

The plaintiff claims she received a Zofran prescription during her first trimester of pregnancy in order to relieve morning sickness symptoms and was unaware that Zofran was not an FDA approved nausea medicine for pregnancy.

The Zofran lawsuit accuses drug manufacturer GlaxoSmithKline of marketing their product “off label” to obstetrics and gynecological practitioners as a safe and effective treatment for morning sickness during pregnancy when they had no clinical evidence to prove that.

The plaintiffs also allege GlaxoSmithKline knew that the drug caused Zofran birth defects yet concealed the information from the medical community and consumers.

Bicuspid aortic stenosis is like most congenital heart defects in that it only occurs during the first stages of fetal development. The first stage of pregnancy is typically when women seek morning sickness relief and as in this case, prescribed Zofran for nausea.

Bicuspid aortic stenosis occurs when a child is born with only two aortic valve leaflets flaps a condition that makes it very difficult to function properly as human hearts usually have three.

The three flaps open which allows blood to flow into the aorta and close to stop it from flowing back. When a heart contains only two leaflets blood can flow backwards forcing the left ventricle to work much harder in order to pump blood through the body. The congenital heart condition can lead to heart failure. The plaintiffs in this Zofran lawsuit suggest their child’s condition is worsening.

Zofran Birth Defects Research

Zofran was approved by the U.S. Food and Drug Administration to be used to treat severe nausea in cancer patients going through treatment. However, it didn’t take long before physicians began prescribing it “off label” to treat nausea associated with morning sickness. 

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

Recent studies have shown a significantly increased risk of Zofran birth defects in women who took the nausea medication during pregnancy compared to nonusers. A 2013 Danish study followed hundreds of thousands of women throughout their pregnancy and found women who took Zofran during the first trimester were 20 to 40 percent more likely to have a child born with a serious birth defect.

Likewise, a 2014 Swedish study found women who took Zofran during pregnancy had a 60 percent greater risk of having a child born with heart defects. An Australian study showed similar results after studying 100,000 births; they found women who consumed Zofran had a 20 percent increased chance of birth defects.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Lawsuits

There have been hundreds of reports of Zofran birth defects and numerous Zofran birth defect lawsuits have been filed so far. Some of the most common birth defects include:

  • Cleft lip
  • Cleft palate
  • Kidney defects
  • Musculoskeletal defects
  • Congenital heart defects
  • Kidney defects
  • Intrauterine death
  • Stillbirth

If you had a child born with a Zofran birth defect, you may have legal claim.

The Zofran Birth Defect Lawsuit is Case No. CGC-15-544524, in the Superior Court for the State of California, County of San Francisco.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The birth defect attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Zofran lawsuit or Zofran class action lawsuit is best for you. [In general, Zofran lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

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Get Help – It’s Free

Join a Free Zofran Birth Defects Class Action Lawsuit Investigation

If you or someone you know took Zofran while pregnant and had a baby with a birth defect, you or this person may have a legal claim. See if you qualify by filling out the short form below.

A Zofran birth defect attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

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