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Zofran Lawsuit

pregnant woman cradling bellyZofran (ondansetron) is an anti-nausea drug from GlaxoSmithKline approved for use in cancer patients. A large number of pregnant mothers suffering from severe morning sickness claim that their “off-label” use of the drug, as prescribed by their physicians, has been a lifesaver during the first weeks of pregnancy when crippling morning nausea is at its worst.

A growing number of other mothers who used the drug during pregnancy are raising concerns that Zofran has not been adequately tested to see if it’s safe for pregnant mothers to use. These women also allege that Zofran may cross the uterine barrier and negatively impact the developing fetus–and that GlaxoSmithKline knew of these risks, but chose to ignore them when it promoted Zofran as a treatment for morning sickness. Some women have filed product liability lawsuits against the drug maker, claiming that their newborns’ birth defects – including heart defects, and cleft lip & palate – were directly caused by Zofran. As evidence for this claim, plaintiffs cite medical studies that have shown a correlation between certain birth defects and Zofran use during pregnancy.

GlaxoSmithKline denies these allegations, pointing out that research on ondansetron’s in utero impact is preliminary and has not clearly established a causal link between Zofran and birth defects. The drug company insists that Zofran is safe for use in pregnant mothers.

So who is right? What does the scientific evidence really show? Is it legal to prescribe drugs “off label”? And who is eligible to file a Zofran lawsuit?

What is Zofran?

Zofran is the brand name for a powerful anti-nausea drug clinically known as ondansetron that was developed by GlaxoSmithKline to treat nausea and excessive vomiting. It was specifically approved by the U.S. Federal Drug Administration (FDA) in 1991 to counter the severe nausea in patients undergoing radiotherapy, chemotherapy, and surgical anesthesia. Available by injection or orally, it is an anti-emetic (anti-nausea) medication belonging to a class of drugs known as 56HT3 receptor antagonists which works by blocking a neurotransmitter called serotonin in the area of the brain that triggers feelings of nausea.

Off-label use of Zofran

Although Zofran was formally approved by the FDA to treat nausea and vomiting in specific cases, doctors began to see positive results in administering it without FDA approval to children with stomach problems and pregnant mothers with morning sickness. This successful off-label (unapproved) use of ondansetron did not escape GlaxoSmithKline, who began to market Zofran to a huge new market—pregnant women.

Zofran quickly became the leading off-label medication for use by pregnant women to combat morning sickness. This type of off-label use is not unusual, not illegal, and also not regulated by the FDA. However, the Federal Food, Drug & Cosmetic Act explicitly bans drug manufacturers like GSK from promoting the sale of any drug that has not been approved by the FDA for that specific use. GlaxoSmithKline would have had to conduct clinical trials to ascertain if the drug was safe for pregnant women. These trials would be a prerequisite for Zofran to be approved for FDA use during pregnancy.

Did GSK test Zofran on pregnant animals?

Plaintiffs in Zofran lawsuits claim that as early as the late 1980’s—prior to FDA approval of Zofran for nausea—GSK had conducted trials on pregnant animals and reported to the FDA that ondansetron showed no harm to the fetuses. On the contrary, according to court papers submitted by plaintiffs in Zofran suits against GlaxoSmithKline, these animal trials “revealed clinical signs of toxicity, premature births, intrauterine fetal deaths, and incomplete bone growth.”

The plaintiffs also claim that GlaxoSmithKline has received over 200 reports of birth defects alleged “to be associated with Zofran use during pregnancy.” But rather than submit these adverse reports to the FDA, the plaintiffs claim, Glaxo withheld the reports and steadfastly refused to conduct studies to determine if Zofran was safe for use by pregnant women because it would have hampered its marketing efforts and cut into its profits.

Are Zofran studies conclusive?

A 2013 study published in the New England Journal of Medicine that analyzed information from the Danish Medical Birth Registry for the years 2004-2011 did not establish a clear causal link between the use of Zofran during pregnancy and congenital birth defects. Critics questioned the study because Zofran was introduced to the subjects after the tenth week of gestation, when most risks of birth defects have already passed.

A second expanded study done by Dr. Gideon Koren on the same registry, but going back to 1997, showed very different results. That study, published in 2014 in the American Journal of Obstetrics and Gynecology found a “two-fold increased risk of cardiac malformations with Zofran, leading to an overall 30 percent increased risk of major congenital malformations.”

Other published studies on Zofran side effects have found:

  • A team of Harvard researchers found a two-fold increase in cleft palates in infants whose mothers used Zofran during the first trimester. Researchers indicated that these results were not conclusive, but “warrant further investigation.”
  • The findings of a Swedish research team concurred with the expanded Danish study, finding that infants were 1.62 times more likely to have heart defects if their mothers used Zofran.
  • A team of Australian researches found “a 20% increased risk of a major birth defect amongst children exposed to ondansetron in the first trimester,” and concluded that they “could not conclude that ondansetron is safe to use in pregnancy.”

U.S. Department of Justice and GlaxoSmithKline

In 2012, the Department of Justice brought civil and criminal charges against GlaxoSmithKline over fraudulent promotion of several drugs, including Zofran. The DOJ also claimed that GSK had provided illegal remuneration to physicians to induce them to promote & prescribe Zofran. GlaxoSmithKline resolved these allegations by agreeing to a settlement of $3 billion.

For its part, GSK has always denied and continues to deny any liability in regard to Zofran.

Zofran lawsuits

Zofran lawsuits currently in the courts are claiming damages for a wide range of congenital heart defects including atrial septal defect, ventricular hypertension, aortic arch hypoplasia, aortic stenosis, supraventricular tachycardia, and malformed arteries.

Other birth defects allegedly linked to Zofran, according to these product liability lawsuits, include cleft palate and cleft lip, club foot, craniosynostosis (malformed skull), and developmental delays.

One early case was filed in Massachusetts by a mother whose daughter has suffered through 10 surgeries in 12 years to correct heart defects, facial dysmorphia, low set ears, hearing loss, webbed toes, light sensitivity, and an inguinal hernia—all of which she attributes to her use of Zofran during pregnancy.

Zofran lawyers across the country are currently reviewing cases of children who were born with heart defects, cleft lip or palate, or other physical malformations that may be the result of ondansetron exposure in utero. Mothers who suspect that their child’s birth defects may be the result of using Zofran to combat morning sickness are advised to speak with an experienced dangerous drug lawyer to learn more about the legal avenues open to them in the pursuit of justice.

  1. AJOG, Treating morning sickness in the United States—changes in prescribing are needed,

  2. NCBI, Is Ondansetron Safe for Use During Pregnancy?

  3. National Institutes of Health, Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects.

  4. BioMed Research International, Off-Label Use of Ondansetron in Pregnancy in Western Australia,

  5. National Institutes of Health, Use of ondansetron during pregnancy and congenital malformations in the infant.