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Zofran Lawsuit Claims Nausea Drug Caused Kidney Defects, Monheit Law Reports

In the latest lawsuit to claim Zofran caused birth defects, parents from North Dakota say nearly continuous prenatal exposure to the anti-nausea drug led to a child’s missing kidney. The family’s claim, brought against GlaxoSmithKline, Zofran’s manufacturer, was filed in the US District Court for North Dakota, Southwestern Division. A copy of court documents, registered as case number 1:15-cv-00102-CSM, can be found here.

Michael Monheit, Esquire, managing partner of Monheit Law and lead sponsor for, says 33 other claims have been filed against GlaxoSmithKline in relation to major birth defects allegedly caused by Zofran. But most claims have been filed in relation to congenital heart defects, Monheit says. He notes two major studies, conducted in Denmark and Sweden, that have found a marked association between Zofran and cardiac septal defects, in which walls of the heart fail to form properly.

While several claims have been filed in relation to cleft palate, an abnormality also linked to Zofran by medical researchers, the new complaint in North Dakota may be the first to mention kidney defects.

In their lawsuit, residents of North Dakota capital Bismarck say almost constant exposure to Zofran led to their son’s numerous birth defects. The mother claims that she was prescribed the drug, frequently used as an “off label” (unapproved) morning sickness treatment, early in the first trimester of her pregnancy. She continued taking the drug, both in pill form and intravenously, for the remainder of her pregnancy, delivering her son G.K. in 2007.

According to the complaint, G.K.’s early life was active; the parents say their son enjoyed soccer and basketball. But in 2013, six years after his birth, an accident at home would change G.K.’s life forever, the family writes. In October of that year, G.K. suffered a serious injury to his kidney and was rushed to the emergency room of a nearby hospital. It was here, after a series of diagnostic tests, that G.K.’s parents would first learn their son was missing a kidney. In need of immediate medical intervention, the boy was airlifted to a facility in Minneapolis, where he was hospitalized.

G.K.’s existing kidney functions at only 38% of a healthy kidney, Plaintiffs claim, presenting a serious threat to his life. The risk of death or severe injury, their doctors say, could become a reality at the “slightest aggravation.” G.K. has been told he can never play sports again, his parents write.

If the family’s claims are true, G.K. was born with a condition called unilateral renal agenesis, in which one kidney fails to develop because the cellular structures out of which it would form are themselves absent. In the Plaintiffs’ own words, this leaves G.K. without the “necessary connective tissues to allow for a kidney implant.”

The Minnesota Department of Public Health notes that “kidneys develop between the 5th and 12th week of fetal life,” well within the first trimester in which Plaintiff claims she was prescribed Zofran.

G.K. is also missing one of his vas deferens, his parents write; the tube that should carry sperm from one of his testes to his urethra is entirely absent. This condition is not unheard of among children born without a kidney. During early fetal development, an organ known as the mesonephric duct eventually separates into the kidney and portions of the male reproductive system. The boy’s parents express concerns that he may never “be able to have any normal male sexual function at all.”

With this new lawsuit filed in North Dakota, the Zofran litigation has grown to over 33 individual personal injury claims. But significant changes may be on the way, according to Michael Monheit.

GlaxoSmithKline, along with many Plaintiffs, has expressed a desire to have all Federally-filed Zofran birth defect lawsuits transferred to a single Federal Court for consolidated pretrial proceedings. Plaintiffs, however, have disputed GlaxoSmithKline’s preferred venue: the US District Court for the Eastern District of Pennsylvania. As a more appropriate venue, Plaintiffs have suggested courts in Alabama, Ohio and Massachusetts, among other states. It remains to be seen whether the Judicial Panel on Multidistrict Litigation will choose to consolidate Zofran claims at all.

For the present, Michael Monheit continues to provide free consultations to families who believe that prenatal exposure to Zofran may have caused a child’s birth defects. He has joined together with a coalition of nationally-recognized plaintiffs’ attorneys to pursue claims against GlaxoSmithKline. For more information, call 1-877-620-8411 or visit



Michael Monheit
1368 Barrowdale Road, Rydal, PA 19046

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