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At least four large-scale epidemiological studies have linked prenatal exposure to ondansetron, a powerful anti-nausea drug, with an increased risk of major birth defects.

Zofran Birth Defect Lawsuits

Ondansetron, manufactured by GlaxoSmithKline under the brand name Zofran, is approved by the FDA to treat severe nausea and vomiting only in patients undergoing:

  • chemotherapy
  • radiotherapy
  • surgical anesthesia

Testing Zofran for birth defect risksIt has never been approved as a treatment for “morning sickness,” the nausea and vomiting that commonly accompanies early pregnancy. Nor has GlaxoSmithKline conducted clinical trials to determine its effects in pregnant women, trials that are required before a medication can be approved for use specifically during pregnancy.

Did GlaxoSmithKline Promote Zofran Unlawfully?

Notwithstanding these facts, Zofran has seen a surge in prescription sales, and doctors across the globe have made it a leading, albeit “off-label,” treatment for morning sickness.

Prescribing drugs for unapproved, or “off-label,” uses is a common practice, and one not regulated by the US Food & Drug Administration (FDA). But under provisions outlined in the Federal Food, Drug & Cosmetic Act, pharmaceutical manufacturers are prohibited from promoting drugs for any uses not approved by the FDA.

Federal Government Claims Zofran Was Promoted For Use During Pregnancy

In 2012, the US Department of Justice charged GlaxoSmithKline with a number of civil and criminal charges.

Several of these charges explicitly involved Zofran. The federal government alleged that GSK had:

  • “promoted the sale and use of Zofran for a variety of conditions other than those for which its use was approved as safe and effective by the FDA (including hyperemesis or pregnancy-related nausea)
  • made and / or disseminated unsubstantiated and / or false representations or statements about the safety and efficacy of Zofran concerning [its off-label use to treat morning sickness]
  • offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Zofran.”

GlaxoSmithKline ultimately pleaded guilty to three of the government’s criminal charges, none of which involved Zofran, and entered a settlement agreement for $3 billion.

And while the company continues to deny allegations that it promoted Zofran for off-label use, a wave of newly-filed personal injury lawsuits maintain that the company unlawfully marketed its anti-nausea drug to doctors as a treatment for morning sickness.

Families Are Now Filing Zofran Birth Defect Lawsuits

In at least six lawsuits, parents from across the nation have alleged that prenatal exposure to Zofran caused their children to be born with major birth defects.

Claims have now been filed in Massachusetts, Minnesota, California, Montana and Texas, and are registered under the docket numbers:

  • 1:15-cv-10429
  • 2:15-cv-00709PD
  • CGC-15-544524
  • R615761042
  • 1:15-cv-00026-SPW-CSO
  • 5:15-34

Overviews of each lawsuit, along with downloadable .PDF versions of the filed complaints, can be found at the Zofran National Legal Resource Center.

What Have Plaintiffs Alleged In Their Zofran Lawsuits?

Like the US Department of Justice, plaintiffs claim that GlaxoSmithKline promoted Zofran as a “safe and effective” treatment for morning sickness, without any of the evidence necessary to support such a claim.

Plaintiffs Claim That GlaxoSmithKline Has Been Aware Of Zofran’s Risks For Decades

But their other allegations are far more troubling. Plaintiffs allege that GlaxoSmithKline has been aware of Zofran’s potential to cause birth defects for more than 20 years, but chose to ignore mounting evidence of the drug’s risks in order to preserve record profits.

After noting the multiple studies that have found an association between Zofran’s active ingredient and birth defects, plaintiffs point to a series of reports they say GlaxoSmithKline began to receive as early as 1992. To date, they claim that GlaxoSmithKline has received at least 200 reports of “birth defects associated with Zofran use during pregnancy.”

But rather than submit these reports to the FDA, claimants say GlaxoSmithKline intentionally avoided conducting studies to determine Zofran’s effects in pregnant women “because they would have hampered its marketing of Zofran and decreased profits.”

They also claim that GlaxoSmithKline downplayed the results of studies conducted on pregnant animals in the late 1980s. Citing four trials involving pregnant rats and rabbits performed prior to Zofran’s approval, plaintiffs allege that GlaxoSmithKline told the FDA that the studies “showed no harm to the fetus.” According to claimants, these trials actually “revealed clinical signs of toxicity, premature births, intrauterine fetal deaths and […] incomplete bone growth.”

Plaintiffs claim that despite GlaxoSmithKline’s own awareness of this mounting evidence, the company continued its allegedly off-label promotion of Zofran as a morning sickness treatment.

For a comprehensive discussion of the allegations made in these Zofran birth defect lawsuits, visit this page.

Which Birth Defects Have Been Associated With Zofran?

As we’ve noted elsewhere, at least four epidemiological studies have found an increased incidence of major birth defects among babies exposed to Zofran’s active ingredient during the first trimester.

  • Researchers at Harvard University found a two-fold increase in cleft palate.
  • A Danish study found that babies exposed to ondansetron in early pregnancy were more than twice as likely to be born with congenital heart defects, specifically atrial septal defect and atrioventricular septal defect. The risk of atrioventricular septal defect was more than 4 times as great.

You can learn more about these congenital heart defects here.

  • Swedish researchers supported these results, finding that unborn babies exposed to ondansetron were 1.62 times more likely to be born with congenital heart defects.
  • A team in Western Australia found a 7-fold increase in the risk of kidney malformations.

In the new Zofran birth defect lawsuits, plaintiffs claim compensation for the following congenital abnormalities:

  • Congenital heart defects, including atrial septal defect, right ventricular hypertension, aortic arch hypoplasia, bicuspid aortic stenosis, supraventricular tachycardia and thickened arteries
  • Cleft lip and cleft palate
  • Developmental delays

Learn More About Your Case Eligibility

If you were prescribed Zofran as a treatment for morning sickness during the first trimester, and then delivered a child with birth defects, you may be eligible to bring a claim against GlaxoSmithKline.

Joined by a coalition of distinguished attorneys, Monheit Law is currently offering free legal consultations to parents and birth defect survivors. Families interested in learning more about this ongoing litigation are urged to contact Monheit Law.

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