August 10, 2015 — A lawsuit has been filed by the parents of a boy who was born with only one low-functioning kidney after he was exposed to Zofran in the womb.
The lawsuit (PDF) was filed in federal court in North Dakota on July 27 against GlaxoSmithKline (GSK), the manufacturer of Zofran. The plaintiffs, Angela and Bryan Kutzer, gave birth to a boy (“G.K.”) in 2007.
The boy was not diagnosed with a kidney defect until October 2007, when he was hospitalized after an injury at home. Doctors discovered that he was missing a kidney and connective tissues necessary for a kidney transplant. His remaining kidney had only 38% of its function remaining.
He was also missing the vas deferens, which means he will have extreme difficulty producing children and may have sexual dysfunction as an adult.
The lawsuit claims GSK marketed Zofran “off-label” to pregnant women with morning sickness, but never tested it for safety or warned about the potential risk of birth defects:
“Had plaintiffs known the truth about Zofran’s unreasonable risk of harm, long concealed by GSK, plaintiff Angela Kutzer would have never taken Zofran, and her child G.K. would never have been injured.”
Last year, the Toronto Star published an investigation linking Zofran with kidney malformations. In 2013, a study linked Zofran with a 20% increased risk of birth defects and a 6-fold increased risk of kidney defects, but could not draw any conclusions because the sample size was too small.
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