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Pharmaceutical Litigation

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Do I Have a Zofran Case?

If your child was born with birth defects after you took Zofran during your pregnancy, or if you have suffered harm from this drug, it is in your best interest to consult with a knowledgeable pharmaceutical litigation attorney. You may have a case against the manufacturer, GlaxoSmithKline.

Civil lawsuits have already been filed in the U.S. against this pharmaceutical giant by parents of children who were born with birth defects attributed to the use of this drug. On August 13, 2015, the National Law Journal reported that more than 30 lawsuits had been filed in which parents alleged that their children suffered birth defects caused by taking Zofran for morning sickness during pregnancy.

On October 13, 2015, the United States Judicial Panel transferred twelve such cases filed by parents in Alabama, Arkansas, Louisiana, Massachusetts, Montana, New Jersey, Ohio, and Texas to multi district legislation in the U.S. District Court of Massachusetts before The Honorable F. Dennis Saylor IV for consolidated or coordinated pretrial proceedings. Many more parents suing GlaxoSmithKline for birth defects suffered by their infants joined in this multidistrict legislation, and according to an article in World Now, as of February 17, 2016, the number of cases has exceeded 220.

At Farah & Farah, we have devoted our practice to representing people injured by dangerous drugs and devices. We fight relentlessly for our clients, to recover compensation for the losses they have suffered. We are committed to holding the big pharmaceutical companies accountable for the harm dangerous products cause. We are currently accepting cases nationwide for people who have been seriously injured by Zofran.

Zofran Is Not FDA Approved for Use During Pregnancy

Ondansetron (Zofran) is an anti-nausea drug approved by the FDA for use by cancer patients receiving chemotherapy or radiation therapy, and to prevent nausea after surgery. It has never been approved for use during pregnancy. In fact, the FDA issued a warning in 2013 of a potential safety issue involving increased risk of serotonin syndrome – a life-threatening condition – in patients taking Zofran.

In spite of the fact that it has not been approved for use during pregnancy, doctors have been prescribing Zofran “off label” for pregnant women with severe morning sickness, which typically occurs during the first trimester of pregnancy. The first trimester is a crucial development period for the fetus, and recent research links the use of Zofran during this time to a number of birth defects.

Birth Defects Linked to Zofran

Several recent studies have linked birth defects to the use of Zofran in early pregnancy:

  • Heart Defects: Researchers in Denmark published a study in August 2013 in which an increase in the prevalence of major congenital heart defects was found in children whose mothers filled a prescription for Zofran during the first three months of pregnancy. These serious birth defects can involve holes in the walls between the heart’s upper or lower chambers that allow deoxygenated blood and oxygenated blood to mix, creating abnormal pressure in the heart or the lungs. The most serious cases involve a large hole in the center of the heart that allows blood to pass between all four chambers and a single, defective valve in the center of the heart, instead of two separate valves, as found in a normal heart.
  • Craniofacial Defects: A study published by the American Journal of Obstetrics & Gynecology (AJOG) in December 2014 found a 2-fold increased risk of infant cleft palate when ondansetron (Zofran) was taken during the first trimester.
  • Kidney Defects: In December 2013, the National Center for Biotechnology Information (NCBI) published a study conducted in Western Australia in which researchers found an overall 20% increase in the risk of birth defects with the use of Zofran during the first trimester and a 6-fold increase in the risk of kidney defects (although the kidney-defect findings were based on a small number of cases). This study states that it could not conclude that ondansetron (Zofran) is safe to use in pregnancy.

If you took Zofran during pregnancy on your doctor’s advice and your child was born with a birth defect, call Farah & Farah at (800) 533-3555 right away. You may be entitled to file a claim for compensation against GlaxoSmithKline or other responsible parties. Damages you may be entitled to claim include medical expenses, lost earnings, emotional pain and suffering, and other losses. Our Zofran lawsuit attorneys can discuss the details of your situation in a free case consultation and advise you of your legal options. We handle our Zofran cases on a contingency fee basis, so you pay us no fees until we recover compensation for you.


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Who We Are

The pharmaceutical litigation attorneys at Farah & Farah go after negligent corporations that put unsuspecting consumers in harm's way. Pharmaceutical companies not only have a duty to manufacture drugs that are safe, but they also have the obligation to warn consumers regarding dangerous side effects that can be caused by these drugs.

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