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20 Year-old Woman Files Zofran Complaint

zofran bottle

A 20-year-old woman has filed a Zofran lawsuit in California. The case seeks to hold defendants GlaxoSmithKline and McKesson Corporation responsible for the birth defects that the plaintiff suffered after her mother took Zofran during pregnancy.

The Texas woman filed her complaint in the United States District Court for the Northern District of California on November 30, 2015. According to the complaint, she seeks more than $75, 000 in compensation for damages including medical bills and reimbursement for the purchase of Zofran, as well as punitive damages.

Plaintiff born with birth defects

The plaintiff was born in 1995 with congenital heart defects and orofacial defects. Her mother had been prescribed and taken Zofran to control morning sickness. The ingestion of Zofran started in the beginning of the first trimester of her pregnancy.

After her birth, pediatricians and specialists examined the plaintiff and concluded that she suffered from serious birth defects including a ventricular septal effect in her heart with pulmonary stenosis and a cleft lip and cleft palate. She has already undergone three surgeries to treat the orofacial conditions and will need another surgery in the future. The plaintiff states in her court papers that the birth defects have impaired her development, interfered with her enjoyment of life, and left her with a speech disability.

The lawsuit alleges that there is no genetic cause or family history for these defects, possibly strengthening the claim that they were caused by Zofran exposure. The plaintiff claims her mother would not have taken Zofran if she had known of the risk of harm to a developing child who has been exposed to the medication prenatally.

About Zofran

Zofran is a high-strength anti-nausea drug that the defendants specifically formulated to treat the serious sickness and vomiting that accompanies chemotherapy. The U.S. Food and Drug Administration (FDA) approved it in 1991 to treat cancer patients. Without any further FDA approval, the defendants allegedly marketed the drug “off label” for treatment of common morning sickness in pregnancy.

Plaintiffs in similar lawsuits across the country have alleged that the manufacturer never sought FDA approval of Zofran for use during pregnancy and went a step further by allegedly excluding pregnant women from their trials. This exclusion prevented the manufacturer – or the FDA – from obtaining any data on the safety of in utero exposure.

Zofran maker target of birth defect lawsuits

According to White and other Zofran plaintiffs, GlaxoSmithKline have intentionally marketed the drug to treat common morning sickness. In 2012, GlaxoSmithKline agreed to a$3 billion settlement with the federal government to resolve liabilities over this type of off-label promotion of Zofran and other drugs; there has been no admission of liability and the manufacturer has not admitted to any wrongdoing.

Dozens of families across the nation have filed lawsuits regarding Zofran and birth defects. The number has grown so large that the U.S. Judicial Panel on Multidistrict Litigation has consolidated the federal cases into a multidistrict litigation (MDL) proceeding in Boston.

There are more than 100 cases pending in the Boston MDl, which is overseen by Judge F. Dennis Saylor.