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Filed in courts across the country, Zofran lawsuits continue to make their way to the US District Court of Massachusetts, where more than 200 similar claims are already pending.

Consolidated as a “Multi-District Litigation,” the lawsuits, all of which allege that GlaxoSmithKline’s potent anti-nausea medication caused a child’s birth defects, will continue together through pre-trial proceedings.

Utah Parents Say Zofran Caused Daughter’s Cleft Lip & Palate

Although most of the lawsuits assert a link between Zofran and congenital heart defects, the newest lawsuit slated for transfer is different. In a lawsuit initially filed in the US District Court for the District of Utah, Central Division, a family says prenatal exposure to the drug caused their daughter’s cleft lip and cleft palate.

The family’s lawsuit was filed on February 19, 2016, and registered under the case number 2:16-cv-00131-EJF. The US Judicial Panel on Multi-District Litigation issued a “Conditional Transfer Order,” requesting the lawsuit’s transfer to Boston, on March 2, 2016. Attorneys for the family now have 7 days to oppose the lawsuit’s transfer, if they deem such action in their clients’ best interests.

Has Zofran Been Linked To Cleft Palate Before?


While this is far from the first Zofran lawsuit filed for orofacial defects, the new complaint has renewed interest in a 2012 study, one that found an association between Zofran taken during the first trimester of pregnancy and an increased risk for cleft palate.

Researchers at Boston University and Harvard’s School of Public Health used maternal interviews and birth records to identify young children who had been exposed to Zofran during the first trimester of pregnancy. Comparing these babies to ones who had not been exposed to the drug, the authors found that exposed babies were more than twice as likely to be born with cleft palate.

In their own lawsuit, the Utah family cites this study as evidence of Zofran’s potential to cause harm, writing:

“a recent large control study detected a more-than 2-fold increased risk for cleft palate associated with ondansetron [Zofran’s active ingredient] taken in the first trimester of pregnancy.”

You can learn more about the association between Zofran and cleft palate at

Were Patients Ever Warned?

GlaxoSmithKline, however, has never publicized this information, the family claims. Nor has the company made patients or doctors aware of 3 studies that Plaintiffs say show a troubling association between Zofran and congenital heart defects. In contrast, the company has “marketed and sold Zofran without adequate warning to healthcare providers and consumers that Zofran was causally associated with increased risks of birth defects,” the family writes.

In fact, rather than warn pregnant women of the drug’s potential risks, Plaintiffs say GlaxoSmithKline actively marketed Zofran as a morning sickness treatment – in violation of federal law.

GSK Hit With Allegations Of “Health Care Fraud” By Justice Department

Zofran was initially approved in 1991, when the FDA decided it would be a “safe and effective” treatment for chemotherapy patients, who often experience intense nausea and vomiting. While the drug’s official approval would come to cover radiotherapy patients, as well as patients undergoing surgical anesthesia, Zofran has never been approved as a treatment for morning sickness.

Under federal law, drug companies are prohibited from promoting products beyond their explicit approvals. Marketing a drug for an unapproved indication is illegal. But that’s exactly what GlaxoSmithKline did, the family says. Exploiting pre-existing relationships with obstetricians and gynecologists, the complaint reads, GSK began coaxing these physicians into prescribing their pregnant patients Zofran. The company’s alleged “fraudulent marketing” began as early as 1998, Plaintiffs claim, eventually garnering the US Justice Department’s attention.

In 2012, the Department of Justice made a shocking announcement. After years of investigation, and even more filled with contested litigation, GlaxoSmithKline had agreed to pay $3 billion, settling numerous allegations that the company had improperly marketed its drugs. One of those drugs, the government said, was Zofran. In its record-breaking lawsuit, the Justice Department claimed GSK had “promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.” According to the government, the company had even bribed physicians, paying them “illegal kickbacks,” to prescribe more Zofran.

One Family’s Story

GlaxoSmithKline has never admitted to promoting Zofran for use during pregnancy. But the family from Utah is convinced that this illegal promotion took place, and convinced it’s why their daughter was exposed to Zofran.

In court documents, the mother says she was prescribed Zofran early in a pregnancy that began in 1995. She took it, by all accounts, for a very long time, only discontinuing the treatment in January of 1996. Her daughter, named E.M. in the complaint, was born on February 24, 1996. E.M. was immediately diagnosed with a “wide right unilateral complete cleft lip and palate,” a large split running through her upper lip and extending through the roof of her mouth.

The child underwent several surgeries, although the lawsuit does not specify how many or of what nature. Now 20 years old, E.M. “exhibits physical malformations resulting from the clefts and subsequent surgeries,” her parents claim. She “is unable to participate fully in life,” they say, “and has “required […] speech, occupational and physical therapy.”

The family’s lawsuit (PDF) has been made public by Monheit Law, a Pennsylvania-based plaintiffs’ law firm. The firm is currently offering free consultations to families who believe Zofran may have caused a child’s birth defects. For more information, call (877) 620-8411.

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