On April 17, 2015, a mother from Texas filed suit against GlaxoSmithKline, manufacturer of the anti-nausea drug Zofran. Her complaint, filed under case number 5:15-34 in the United States District Court of Texas, Texarkana Division, is the most recent of six claims alleging that Zofran, a drug often prescribed “off label” as a morning sickness treatment, causes birth defects.
Plaintiff claims that after she was prescribed Zofran for the symptoms of morning sickness, her child was born with “numerous birth defects,” including a heart murmur, fluid on the brain, thickened arteries and multiple developmental delays. According to the complaint, her eight month old child “anticipates a long road of multiple surgeries.”
Zofran has never been approved for use during pregnancy, nor has its manufacturer ever conducted clinical trials to determine the drug’s effects on pregnant women or their unborn babies. Under US law, pharmaceutical manufacturers are prohibited from marketing their drugs for uses not approved by the FDA. Plaintiff alleges that GlaxoSmithKline actively promoted Zofran as a treatment for morning sickness, in part by paying illegal kickbacks to doctors who promoted and prescribed the drug themselves. In 2012, the federal government made similar allegations, and while GlaxoSmithKline continues to deny that it promoted Zofran off-label, the company eventually settled the government’s case for $3 billion.
Of the six lawsuits now filed against the company, the Texas complaint is the first to note a recent investigation of GlaxoSmithKline’s business practices in China. Chinese authorities charged five of the company’s managers with bribing doctors to prescribe its products. On September 19, 2014, the New York Times reported that all five managers had pled guilty. In a subsequent press release, GlaxoSmithKline formally acknowledged that its senior managers had overseen what the Times called “a spree of bribe-giving and illicit sales tactics.”
Plaintiff claims that GlaxoSmithKline failed to report mounting evidence that Zofran posed unreasonable risks when prescribed as a treatment for morning sickness. She claims that the company failed to disclose at least 200 birth defect reports associated with the use of Zofran to the FDA, and alleges that GlaxoSmithKline intentionally avoided conducting clinical trials in pregnant women because the company “had knowledge of the drug’s toxicity” and performing these studies would have “hampered its marketing of Zofran and decreased profits.”
Monheit Law has joined with a multi-state alliance of attorneys to investigate the claims of parents who believe that exposure to Zofran may have caused their child’s birth defects. If the allegations made in these recent lawsuits are true, any woman who was prescribed Zofran as a treatment for morning sickness, and then delivered a child with major birth defects, may be eligible to file a claim against GlaxoSmithKline.