May 22, 2015 — GlaxoSmithKline (GSK) has been hit with yet another lawsuit on behalf of a child who was born with severe birth defects after being exposed to Zofran in the womb.
The lawsuit was filed in the Superior Court for the State of California (Alameda). The plaintiff is Oakland resident Sonya Lampkin, the mother of “J.S.,” a child born with birth defects.
To alleviate symptoms of morning sickness, Lampkin used Zofran beginning early in her first trimester of pregnancy. The child was born in 2010 with supraventricular tachycardia (SVT), a heart rhythm disorder that causes rapid breathing, shortness of breath, and shallow breathing.
According to the lawsuit (PDF):
[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.”
The “fraudulent marketing” allegations have been raised several other lawsuits. In 2012, GSK paid a massive $3 billion settlement for marketing several drugs for “off-label” (unapproved) purposes, including pregnant women with morning sickness.
At least three other lawsuits have been filed by women who had a baby with a heart defect after taking Zofran. One of the first lawsuits was filed on behalf of “B.F.,” a child who was born in 2004 with a life-threatening “hole in the heart.” Another lawsuit was recently filed on behalf of “B.C.W.,” a child who was born in 2014 with multiple heart defects.
Zofran has been linked to an increased risk of heart defects in a number of studies. One study published in December 2014 linked the use of Zofran with a doubled risk of septal heart defects (also known as “hole in the heart”).