May 22, 2015 — A woman from Oakland, California has become the latest mom to file a lawsuit against GlaxoSmithKline (GSK) for failing to warn about the risk of birth defects associated with Zofran.
The woman, Sonya Lampkin, gave birth to “J.S.” in 2010. The child was born with a serious abnormal heart rhythm condition known as supraventricular tachycardia (SVT), which causes rapid breathing, shallow breathing, and shortness of breath. The child was prescribed Digoxin to control symptoms of the birth defect.
The lawsuit (PDF) was filed this month in the Superior Court for the State of California, Alameda County (Case No. RG15761042). According to the complaint:
[Plaintiff] was unaware of the dangerousness of Zofran or the fraudulent nature of GSK’s marketing … [Had she] known of the increased risk of birth defects associated with Zofran, she would not have taken Zofran during pregnancy and J.S. would not have been born with congenital malformations.”
Ms. Lampkin is not alone in her complaint — at least three other lawsuits have been filed by women who took Zofran during pregnancy and had a baby with a heart defect. One of the first lawsuits was filed on behalf of a child who was born with a “hole in the heart.”
Last year, a study published in Reproductive Toxicology linked Zofran with a doubled risk of having a baby with a “hole in the heart.” Another study involving 900,000 pregnancies in Denmark also found that Zofran doubled the risk of heart defects.
The lawsuit also accuses GSK of “fraudulent marketing.” In 2012, the Justice Department ordered GSK to pay a $3 billion settlement for illegal marketing. Prosecutors accused the drug-maker of promoting Zofran “off-label” in pregnant women with morning sickness, although this use was not approved or recommended by the FDA.
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