Zofran Lawsuit Filed in Montana District Court

In a recent complaint against Zofran manufacturer GlaxoSmithKline (GSK), two Montana parents have alleged significant failures by GSK to properly warn women of the allegedly known risks of congenital birth defects in babies exposed to the drug in utero. The complaint includes the full history of the testing and approval of Zofran – which is limited to the treatment of chemotherapy patients experiencing extreme nausea – and includes nine causes of action from negligence to intentional infliction of emotional distress.

At the conclusion of the Zofran lawsuit, the plaintiffs assert their demand for a jury trial, and seek compensatory, general and special damages on behalf of their daughter, who was born with a cleft lip and palate. The complaint, which was filed on April 3, 2015, is one of the first involving Zofran (ondansetron) – a prescription drug under increasing scrutiny by pregnant women and their care providers.

Background of plaintiffs’ exposure to Zofran

The plaintiffs initiating the lawsuit are the natural parents of a child born with the congenital defect known as cleft lip and palate – which required ten corrective surgeries and extensive recovery periods. The child’s mother was prescribed Zofran beginning in the early weeks of her first trimester, and was informed by her doctor that the drug was helpful in combatting the side effects of progesterone-induced nausea and vomiting. The plaintiff asserts she was never warned of the possibility of problems with Zofran, and believed it was a safe method to control the debilitating symptoms of morning sickness – which are often pervasive throughout the day.

According to the plaintiff’s allegations, if she had known about the risks of fetal injury associated with Zofran, she would have never taken the drug, and her child would have avoided the pain and injury associated with her condition. Accordingly, both parents allege that the manufacturer has known for decades that Zofran can cause fetal death, disfigurement, or birth defects in laboratory test animals.

Zofran testing and approval

The plaintiffs’ complaint contains a litany of allegations as to the testing measures, studies, and knowledge obtained by GSK and third-party researchers as to the safety of Zofran in pregnant women. In the 1990’s, Zofran entered the market following its FDA approval for the treatment of extreme nausea and vomiting in chemotherapy patients, a condition known as emesis. However, as early as the 1980’s, GSK is alleged to have studied the side effects of Zofran on pregnant laboratory rats and rabbits, resulting in the conclusion that Zofran is capable of crossing the placental barrier.

By 2000, the FDA had received a purported 32 reports linking Zofran to subsequent birth defects in developing fetus, alleged to include “congenital heart disease, dysmorphism, intrauterine death, stillbirth, kidney malformation, congenital diaphragmatic anomaly, congenital musculoskeletal anomalies, and orofacial anomalies, among others.”

Moreover, the plaintiffs contend that GSK engaged in unlawful and deceitful off-label marketing of Zofran, and encouraged practitioners and patients alike to take the drug for the treatment of emesis in pregnant women. Off-label marketing is a controversial – but common – practice in which drug companies market and advertise drugs for uses not expressly approved by the FDA. The practice can trigger False Claims Act liability with regard to Medicaid and Medicare patients, and is generally considered risky – especially within the context of pregnancy and fetal development.

Plaintiff alleges nine causes of action against GSK

Based on the alleged facts and research-based evidence presented in the complaint, the plaintiffs have asserted nine causes of action against GSK, including:

• Negligence
• Negligence per se (i.e., negligence derived from statute)
• Strict products liability
• Fraudulent misrepresentation
• Fraudulent concealment
• Negligent misrepresentation
• Breach of express warranty
• Breach of implied warranty of merchantability
• Infliction of emotional distress

This case marks the fourth known Zofran lawsuit alleging birth defects pending in the United States. Others include cases in Pennsylvania, Massachusetts, and California – all asserting similar unlawful marketing and failure to warn allegations.

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