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Many women who are pregnant suffer from nausea and frequent vomiting. When this condition becomes too severe for expectant mothers, doctors often prescribe something to help prevent the symptoms. One of the most prescribed drugs has been Zofran. Zofran was touted to block nausea and vomiting signals that are sent to the brain. Although Zofran was approved by the FDA to treat the symptoms of nausea and vomiting in patients undergoing chemotherapy as well as some patients undergoing certain types of surgery, many doctors also prescribed the drug to treat morning sickness in pregnant women.

Three years ago, the CDC published a study that revealed a link between mothers-to-be who took Zofran in their first trimester and babies born with congenital abnormalities. The reported birth defects were:

  • Craniosynostosis (skull deformities)
    • This birth defect is a result of the joints between the bones of a fetus’ skull closes prematurely, before the brain is fully formed.
  • Pulmonary Hypertension of Newborn (PPHN)
    • This is a life-threatening condition that decreases a baby’s supply of oxygen after birth. Before the baby is born, their blood circulation is different. When born, their circulation does not change to what a normal newborn should have.
  • Lung defects
    • Lung damage occurs when a ventricular septal defect in the heart creates too much pressure in the lungs.
  • Jaundice
    • Jaundice in a newborn whose mother took Zofran can indicate serious liver damage, affecting a newborns ability to break down and remove toxins from its body.
  • Kidney defects
    • Defects of the kidney are due to “obstructive defects of renal pelvis and ureter”, which cause kidney failure.
  • Heart defects or damage, which includes:
    • Atrial Septal Defect: This is an opening in the wall between the upper-left and upper-right chambers of the heart
    • Ventricular Septal Defect: This is a "hole in the heart" defect between the lower-left and lower-right chambers
    • Heart Murmur: This is an abnormal or extra sound heard in the heart using a stethoscope
  • Club foot
    • During pregnancy, the fetus’ feet are rotated at the ankle, resulting in one or both feet being both smaller and shorter than normal.
  • Spina bifida
    • This birth defect can occur anywhere on the baby’s spine and means that part of the spinal cord develops outside of the body.
  • Cleft lip or palate
    • Both of these birth defects are a result of a fetus’ lip and/or mouth do not form properly in utero.
  • Internal malformations
    • Zofran may be the cause of many other internal malformation. If your child was born with any type of defect, while you were taking Zofran, contact our skilled lawyers who can help you determine if you have a case.
  • Death

The maker of the drug, GlaxoSmithKline has been accused of marketing Zofran to pregnant women and paying health care professionals to prescribe it. The Department of Justice sued GlaxoSmithKline for unlawful promotion and failure to report safety findings. In 2012, Glaxo agreed to pay $3 billion to resolve charges related to illegally promoting Zofran to treat morning sickness. In the past few months, families with babies who suffered from birth defects are suing GlaxoSmithKline because the drug’s label never contained any safety warnings about congenital abnormalities.

So far, at least three lawsuits have been filed against Zofran, alleging the drug can cause severe birth defects in children whose mothers were prescribed the medication during their first trimester to control morning sickness. The first case was filed in February in the U.S. District Court, Eastern District of Pennsylvania, by a woman who says she was prescribed Zofran during her two pregnancies, and both children were born with heart abnormalities. Shortly following the Pennsylvania woman’s claims, two other lawsuits were filed with similar allegations.

And now, more and more Zofran lawsuits have been filed in U.S. courts regarding children who were born with serious birth defects, due to their mothers taking the drug in early pregnancy. The lawsuits allege several claims against GlaxoSmithKline, including:

  • Glaxo released a defective drug to the public.
  • Glaxo had a responsibility to make certain Zofran was safe before allowing public consumption, but failed to determine safety risks.
  • Glaxo did not warn patients of its potentially dangerous side effects.
  • Glaxo advertised Zofran as a safe drug for treating vomiting and nausea for expectant mothers, even though it was not approved by the FDA for this use.
  • Glaxo tested the drug on animals and deemed it safe for human consumption, but test results showed abnormalities and signs of toxicity.

Our firm has received several inquiries regarding this medication and pending lawsuits. Because of this, we felt the need to educate the public about this drug and its potentially dangerous effects on newborns.

If you or a loved one were prescribed Zofran during pregnancy and a child was born with a birth defect, you need to contact us immediately, as we’re in the process of researching and intend to file claims for clients. Your case deserves to be heard, and you deserve to be compensated for medical expenses (including future medical expenses), lost wages, and pain and suffering. We believe in fair and just compensation for everyone who has been negatively affected by this drug. Please contact us so we can help you and your loved ones receive the justice deserved. Call us at any time to speak with a live attorney at 305-448-8585 or toll-free at 877-448-8585.

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