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California Woman Blames Zofran for her Child’s Cleft Lip and Palate

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On September 1, 2015, plaintiffs filed another Zofran lawsuit in the Central District of California. Though there has been no Zofran MDL established yet, Zofran manufacturer GlaxoSmithKline (GSK) has filed a motion requesting that all federally filed Zofran lawsuits be brought together in one court for pre-trial proceedings. If that happens, this case may be transferred.

For now, it’s proceeding in California. Plaintiffs blame GSK for failing to warn expectant moms about the potential risks for birth defects.

Plaintiff Takes Zofran, Gives Birth to Baby with Cleft Lip and Palate

The FDA approved Zofran (ondansetron) in 1991 to treat nausea and vomiting in patients coming out of surgery, and in those taking chemotherapy for cancer. It was never approved for use in pregnant women. Yet GSK advertised the off-label use to encourage doctors and expectant moms to use it as a solution for severe morning sickness.

According to this case, the plaintiff, a resident of California, started taking Zofran during her first trimester of pregnancy to help alleviate and prevent the symptoms of morning sickness. She continued to use the medication through her second semester. Her daughter was born on October 10, 2012.

The baby was then diagnosed with congenital oral defects including a cleft lip and palate. The plaintiff notes that she has no family history of neural tube birth defects, and that her previous child was born healthy and vibrant. She asserts that her daughter’s birth defects were caused by her exposure to Zofran in utero. The child has had to undergo two surgeries so far to correct the defects.

The plaintiff adds that had she been aware of the risks associated with Zofran, she never would have taken it during pregnancy.

Was GSK Aware of the Zofran-Birth Defects Link?

In her complaint, the plaintiff references an epidemiologic study published in 2012 in which researchers found an increased risk for cleft palate in mothers who took ondansetron during pregnancy. Over 4,500 participants and over 5,800 controls were included in the study, in which researchers were mainly looking for any potential connection between morning sickness and birth outcomes. They found that while nausea and vomiting on their own had no link to birth defects, medications like proton pump inhibitors, steroids, and ondansetron did.

More specifically, the study reported that taking ondansetron during pregnancy doubled the odds that the child would be born with a cleft palate.

The plaintiff also notes that as early as 1992, GSK started receiving reports of birth defects associated with Zofran. By the year 2000, they had received 32 such reports, with birth defects like congenital heart disease, stillbirth, kidney malformation, and orofacial abnormalities. Still, the company failed to create proper warnings for patients and doctors.

From 1992 to the present, GSK received more than 200 reports of incidences in which Zofran was linked to birth defects. In 2012, the company pled guilty to charges of promoting its drugs for off-label uses, and paid more than $1 billion in fines for illegal marketing of drugs, including Zofran.

Plaintiff Seeks in Excess of $75,000 in Damages

The plaintiff in this case brings counts of negligence, liability, fraudulent misrepresentation, fraudulent concealment, and deceptive trade practices. She seeks both compensatory and general damages in excess of $75,000.