The First Lawsuit Alleging Zofran Caused Cleft Palate

  • Date: Apr 23, 2015
  • Category: Family

On April 3, 2015, parents from Billings, Montana became America’s first family to file a lawsuit claiming that GlaxoSmithKline’s anti-nausea drug Zofran caused their child’s cleft palate. In 2012, researchers from Harvard University found that women prescribed Zofran’s active ingredient were twice as likely to deliver babies with cleft palate. Led by Monheit Law, a multistate alliance of attorneys has joined forces to investigate similar claims against Zofran’s manufacturer.

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Apr 23, 2015 /prREACH/ -- During the first four months of 2015, at least five families have brought legal claims against GlaxoSmithKline. The most recent, filed by parents from Billings, Yellowstone County, Montana, alleges that the company’s anti-nausea drug Zofran caused their child’s major birth defects: cleft lip and palate. In 2012, a team of researchers from Harvard University found that women exposed to Zofran’s active ingredient, ondansetron, were more than twice as likely to deliver babies with cleft palate.

Plaintiffs allege that their child, now sixteen years old, “has had to undergo ten surgeries to try and correct her cleft lip and palate. [The] birth defect impairs her development and enjoyment of a normal life at home and at school.” The family’s complaint was filed in the United States District Court of Montana, under docket number 1:15-cv-00026-SPW-CSO.

Plaintiff claims that she was prescribed Zofran as an “off label” treatment for the nausea and vomiting of pregnancy commonly known as “morning sickness.” Zofran is approved by the US Food & Drug Administration for the treatment of severe nausea and vomiting in patients undergoing chemotherapy, radiotherapy and surgical anesthesia. The drug’s manufacturer, GlaxoSmithKline, has never sought its approval as a treatment for morning sickness, and has never conducted clinical trials to determine Zofran’s effects in pregnancy or those it may cause in developing babies.

Despite those facts, plaintiffs in 1:15-cv-00026-SPW-CSO allege that GlaxoSmithKline “marketed Zofran ‘off label’ as a safe and effective treatment” for morning sickness. Under US law, pharmaceutical manufacturers are only allowed to market their products for approved uses. Plaintiffs claim that GlaxoSmithKline promoted Zofran as “safe and effective” during pregnancy, “despite having knowledge that such representations were utterly false, as GSK had never once undertaken a single study on the effects of this powerful drug on a pregnant mother or her growing child in utero.”

These allegations are similar to charges filed in 2012 by the US Department of Justice (DOJ). In a landmark case, the federal government claimed that GlaxoSmithKline had “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” The DOJ claimed that the pharmaceutical company had “paid kickbacks to health care professionals to induce them to promote and prescribe” multiple drugs, including Zofran. While GlaxoSmithKline continues to deny these allegations, the company eventually entered a settlement agreement totaling $3 billion to resolve its criminal and civil liabilities.

But the plaintiffs in Montana’s first Zofran birth defect lawsuit go further. They allege that GlaxoSmithKline “knew that Zofran was unsafe for ingestion by expectant mothers” as early as the late 1980s.

Citing a series of studies allegedly conducted in the 1980s, plaintiffs claim that tests on pregnant animals showed that “Zofran’s active ingredient transfer[s] through the placental barrier [...] and expose[s] fetuses to substantial concentrations.” Further, the complaint alleges that GlaxoSmithKline’s animal studies “revealed evidence of [Zofran’s] toxicity, [including] intrauterine deaths and malformations in offspring.” Plaintiffs claim that GlaxoSmithKline failed to disclose these study results to the FDA.

Plaintiffs allege that, by 2000, GlaxoSmithKline had received at least 32 birth defect reports “associated with the use of Zofran by pregnant women.” The complaint states that “in many instances, GSK received multiple reports in the same month, the same week and even the same day. For example, on or about September 13, 2000, GSK received three separate reports involving Zofran use and adverse events. For two of these incidents, the impact on the baby was so severe that the baby died.”

Plaintiffs claim that GlaxoSmithKline was required to revise Zofran’s warning label and include “a warning as soon as there is reasonable evidence of an association of a serious hazard with a drug,” further noting that, under federal law, the finding of a causal relationship is not necessary. The complaint refers to the “hundreds of reports of birth defects” associated with off-label Zofran use, and claims that these reports would be sufficient to establish an association between Zofran and major birth defects. Plaintiffs allege that GlaxoSmithKline failed in its obligation to alter Zofran’s warning label and failed “to disclose these severe adverse events to healthcare providers or expectant mothers.”

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Michael Monheit


As the father of a child with disabilities I understand the challenges that parents face. We are here to help families with their questions about the law and their rights.
- Michael Monheit
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