Zofran® Birth Defects Lawsuit

Mothers across America who took Zofran® (ondansetron) for morning sickness and have had a child born with one or more birth defects, are hiring lawyers to represent them in a Zofran birth defects lawsuit against GlaxoSmithKline (GSK), the manufacturer of Zofran.

Zofran® is a medication being prescribed “off-label” for pregnant women with morning sickness, yet the drug is not approved by the Food and Drug Administration (FDA) for such use.

Babies are twice as likely to be born with a heart defect or cleft palate if their mother took Zofran while pregnant, according to studies conducted in the United States, Sweden and Denmark.

Zofran® is a medication being prescribed “off-label” for pregnant women with morning sickness, yet the drug is not approved by the Food and Drug Administration (FDA) for such use. The FDA has only approved Zofran for the prevention of nausea and vomiting following surgery and for cancer patients undergoing chemotherapy or radiation.

After its approval in 1991, Zofran’s maker, GlaxoSmithKline (GSK), began marketing the drug “off-label” as a treatment for morning sickness in pregnant women. In likely response to GSK’s marketing of Zofran, doctors began to prescribe Zofran extensively for that off-label indication, even though it was never tested for safety in pregnant women. Zofran became available as a generic drug in 2006.

Please contact our law firm if you took Zofran while pregnant and your child has any of the following birth defects:

  • Abdominal Birth Defects / Omphalocele
  • Anal atresia (complete or partial closure of the anus)
  • Cardiac (heart) defects
  • Cleft palate or cleft lip
  • Clubfoot (one or both feet turn downward and inward)
  • Craniosynostosis (skull defect)
  • Limb Defects
  • Neural-tube defects (brain and spinal cord, spina bifida)
  • PPHN (Persistent Pulmonary Hypertension of the Newborn)

Baum, Hedlund, Aristei & Goldman has extensive experience handling birth defect lawsuits and “off label” cases, where drug companies have promoted to doctors to prescribe their drugs for uses not approved by the FDA. Our firm has handled more than 1,300 birth defect cases related to five different pharmaceutical drugs over the past 10 years.

We have been representing victims of defective drugs since the late 1980s and we have recovered over $4 billion for our past clients in all areas of our practice, including birth defects lawsuits.**

Zofran® Morning Sickness

The Zofran birth defects lawsuit filed by two different women reveals the nature of the complaints being brought by those who took Zofran. In both cases the women were prescribed Zofran to alleviate morning sickness during their pregnancies.

A mother in Boston recently filed a Zofran birth defects lawsuit in the United States District Court of the District of Massachusetts. In her complaint, she states that she began taking Zofran early in the first trimester of her pregnancy. After birth, echocardiograms showed that her daughter (referred to as “A.S.” in the document) had a hole in the wall, or “septum,” that separates the two upper chambers of the heart, a condition known as atrial septal defect (ASD). The aorta, the main artery that supplies oxygenated blood to the body, was also deformed. A.S. was later diagnosed with facial deformities, hearing loss, and other defects. Over a 12 year period, she underwent 10 surgeries to try to correct her defects, which caused “substantial developmental delays,” according to the lawsuit.

In another case, a mother from Minnesota took Zofran to alleviate morning sickness during the first trimester of two pregnancies. Both her children were born with congenital heart defects and later suffered from developmental difficulties. Her Zofran birth defects lawsuit was filed in the U.S. District Court of the Eastern District of Pennsylvania.

In both cases, the mothers had no family history of birth defects and genetic testing did not detect genetic abnormalities.

Failure to Warn Allegations

One of the central allegations of plaintiffs who are suing GlaxoSmithKline is that the drug maker was aware early on that Zofran posed a possible danger to pregnant women but failed to warn them or their doctors. Drug makers are required by FDA regulations to update drug labels as soon as they become aware of “reasonable evidence” of a danger associated with a drug.

  • The offspring of rats and rabbits exposed to Zofran demonstrate toxic effects, including premature births, intrauterine deaths, and incomplete bone growth according to mid-1980s placental-transfer studies performed by GSK.
  • Zofran crosses the placenta and exposes fetuses prenatally to significant levels of the drug, according to the Siu Hong Kong Study, published in 2012.
  • Zofran’s effects on pregnant women have never been studied.
  • GSK has received over 200 reports of birth defects in children exposed to Zofran during pregnancy.

Off-Label Marketing of Zofran®

When a medication is approved by the FDA, it is approved for the treatment of specific medical conditions, under defined circumstances. The FDA approved Zofran for the treatment of nausea and vomiting in cancer patients undergoing radiation and chemotherapy. The FDA did not approve Zofran for use by pregnant women. Despite this fact and the dangers cited above, GSK began promoting Zofran off-label as a safe treatment for morning sickness in pregnant women.

The promotion of a drug for uses not approved by the FDA is known as “off-label” marketing. GSK engaged in off-label marketing of Zofran. In 2012, GSK agreed to pay $3 billion to resolve criminal and civil liability claims filed by the U.S. Department of Justice (DOJ) related to several drugs, including Zofran. According to the DOJ announcement issued on July 2, 2012, GSK agreed to pay $2 billion to resolve its civil liability related to whistleblower claims with the federal government and some state governments under the False Claims Act.

These claims relate to DOJ allegations that GSK promoted Zofran and other drugs for off-label, non-covered uses. The announcement said that, “It further resolves allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women. It also includes allegations that GSK paid kickbacks to health care professionals to induce them to promote and prescribe these drugs….” Unfortunately, doctors are still prescribing it to pregnant women off-label.

Does Zofran® Cause Birth Defects? Scientists Sound the Alarm

Medical researchers have begun to warn of dangers associated with Zofran. Several recent medical studies have linked ondansetron to an increased risk of heart defects and cleft palate in babies exposed to the drug during the first trimester of pregnancy.

  • A December 2014 Swedish study, published in Reproductive Toxicology, found a 62% increase in risk of cardiovascular defects and a two-fold (double) increased risk of cardiac septal defects (“hole in the heart” defects). The authors suggest that Zofran no longer be used in early pregnancy until further study of the drug.
  • At an August 2013 meeting of the International Society of Pharmacoepidemiology in Montreal, Canada, Jon T. Anderson, a researcher at the Copenhagen University Hospital Bispebjerg, reported the results of a study of more than 900,000 births in Denmark. Researchers found that women who took ondansetron during the first trimester had a two- to four-fold increased risk of cardiac septal defects.
  • A January 2013 study funded by the Centers for Disease Control and Prevention, published in Birth Defects Research, Part A: Clinical and Molecular Teratology, found that Zofran increased the risk of cleft palate by nearly two-and-a-half times.

*Our past performance, verdicts or settlements do not constitute a guarantee, warranty, or prediction regarding the outcome of your legal matter.  Past results obtained or overall performance must be confined to that particular case, its factual and legal circumstances and legal surroundings.  Every case is different and must be judged on its own merits.

For Your Free Case Evaluation Please Contact Us

If your child was exposed to Zofran during the first trimester of your pregnancy and was born with one or more birth defects, you may be entitled to compensation. To find out if you have a potential claim against GlaxoSmithKline, please call us at 800-827-0087 or complete the Zofran contact form.

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