Zofran (ondansetron) has become the most prescribed treatment for morning sickness in pregnant women, yet the U.S. Food and Drug Administration (FDA) never approved the drug for this use. Now, women who have taken Zofran are bringing lawsuits against GlaxoSmithKline due to birth defects believed to be caused by the drug.

When the only FDA-approved medication used to treat morning sickness (Bendectin) was withdrawn from the market in 1983, pregnant women needed a new solution. Fast-forward eight years to 1991, and GlaxoSmithKline’s antiemetic drug Zofran received approval to help cancer patients with nausea and vomiting related to chemotherapy, radiation and surgery. Doctors took notice of the effects and began prescribing Zofran for their suffering pregnant patients as an off-label treatment for morning sickness.

Zofran and Birth Defects

Cleft palate, kidney malformation, and heart defect are words a new parent never wants to hear in reference to their newborn baby. But that’s exactly what mothers are claiming resulted from using Zofran during pregnancy. Since morning sickness can put a mother and her unborn baby at risk of malnutrition, many women are prescribed Zofran to prevent nausea and vomiting, and keep their babies safe. Unfortunately, the drug may have had the opposite effect.

Many mothers allege their babies suffered severe birth defects, including congenital heart defects, cleft palates, cleft lips, kidney malformations, skull deformities, and clubfoot, requiring a lifetime of care.

FDA Warning Leads to a Zofran Lawsuit

Although it was never approved for use during pregnancy, Zofran quickly became the top-selling morning sickness drug in the U.S. in the 1990s. While physicians are not restricted from prescribing off-label drugs, pharmaceutical manufacturers are required to promote their products for approved uses only. Concerned that GlaxoSmithKline was marketing the drug in a false or misleading manner, the FDA issued the company a warning letter in March 1999. The agency ordered the company to cease distribution of its promotional materials, noting the failure to include the risks associated with Zofran.

Thanks to a 2003 whistleblower lawsuit kicked off by two former employees of GlaxoSmithKline who claimed the company did in fact promote the off-label use of Zofran for morning sickness, the Justice Department took the company to court in 2011. Despite never accepting liability, GlaxoSmithKline reached a settlement and agreed to pay the government $3 billion. To this day, this is the largest settlement for alleged health care fraud in U.S. history.

More Zofran Lawsuits Filed

Based on the claims of Zofran-related birth defects, GlaxoSmithKline is now the subject of over 430 federal court actions. In 2015, Novartis purchased the oncology division of GlaxoSmithKline, and as a result, it is now also named as a defendant in lawsuits claiming Zofran-related damages after March 23, 2015. The affected families have sued GlaxoSmithKline over allegations that it marketed the drug to pregnant women without FDA approval, paid doctors to prescribe it, and failed to provide warnings about the risks.

The first Zofran lawsuit was filed in February 2015 by a Minnesota mother on behalf of her two daughters born with congenital heart defects. More mothers and families quickly followed suit, with actions piling up in federal courts across the country, including in New Jersey, Texas, Alabama, Ohio, Montana, Louisiana, Arkansas, and Massachusetts.

In October 2015, 12 lawsuits related to Zofran were transferred to the District of Massachusetts as a multidistrict litigation filed under MDL 2657 as a way to improve the efficiency of the proceedings. While the cases remain individual complaints, many have similar claims and evidence, which can be handled much faster as a “master complaint” than going through the court system separately. Many in the legal community insist that the fact that the Zofran litigation has been consolidated in no way restricts the rights of other families. Mothers who gave birth to children with birth defects after being prescribed Zofran may still be able to file suit.

Allegations Against GlaxoSmithKline in the Master Complaint

According to the long-form complaint common to all the participants of MDL 2657, plaintiffs allege that serotonin signaling is an important regulator of embryonic development. In marketing Zofran as a safe morning sickness drug, GlaxoSmithKline (and later Novartis) failed to warn patients, medical providers, and the general public of the potential dangers to prenatal exposure to the drug. Furthermore, since the FDA has never approved Zofran to treat morning sickness, the companies violated federal laws and regulations related to drug marketing.

Court documents show that as early as 1992, GlaxoSmithKline knew that Zofran was linked with an unreasonable risk of harm to unborn babies as it passes through the human placenta during pregnancy. Despite this knowledge, the company continued promoting the drug to doctors and pregnant women for morning sickness. Specific allegations of the Zofran lawsuit state that GlaxoSmithKline:

  • Had a legal obligation to ensure Zofran was safe before releasing it, and failed to determine its safety risks before promoting it
  • Failed to warn the public and medical communities about the risk of Zofran side effects
  • Marketed Zofran as a safe treatment for morning sickness and hyperemesis gravidarum despite its lack of FDA approval
  • Misrepresented animal studies indicating that Zofran was safe, when studies show abnormal bone growth and signs of toxicity
  • Failed to properly analyze all data and safety information regarding Zofran use in pregnant women
  • Manufactured a defective drug
  • Falsely and fraudulently claimed it was safe for pregnant women

Ongoing Zofran Litigation

In January 2017, GlaxoSmithKline asked the U.S. district judge presiding over federal Zofran birth defect lawsuits to dismiss fraud-based claims from multidistrict litigation, arguing that the master complaint is devoid of details about any alleged lies and obfuscations. In April 2017, the judge rejected this request, finding that sufficient allegations have been presented by the plaintiffs to proceed on the basis that the pregnancy warnings for the anti-nausea drug were false and misleading, and thus constitute fraud.

As of March 15, 2017, 434 total actions had been filed as part of MDL 2657. No trial date had been scheduled, and GlaxoSmithKline has offered no settlements in pending cases. Even with concerns about fetal safety and the growing number of lawsuits against GlaxoSmithKline and Novartis, monthly prescriptions of Zofran for morning sickness jumped from 50,000 in 2008 to 110,000 in 2013. Today, there are about 4 million pregnancies per year in the U.S. and nearly 1 million of these women are exposed to Zofran or its generic counterparts.