Zofran First Trimester Pregnancy Use Resulted in Kidney Problems for Baby, Lawsuit Alleges

According to allegations raised in a recent product liability lawsuit filed against GlaxoSmithKline, first trimester use of Zofran caused a child exposed to the anti-nausea drug during pregnancy to suffer various birth defects, including kidney problems.

The complaint (PDF) was filed by Angela and Bryan Kutzer on behalf of themselves and their minor son, identified only as G.K., in the U.S. District Court for the District of North Dakota on July 27.

The Kutzer family alleges that GlaxoSmithKline failed to adequately warn about the potential side effects of Zofran first trimester pregnancy use, which has recently been linked to a risk of severe health problems for unborn children.

After exposure to Zofran during pregnancy, the minor G.K. was born in 2007 with a congenital unilateral renal agenesis, meaning a kidney was missing. He also is missing the connective tissues necessary to allow for a kidney transplant.

The missing kidney was not discovered until October 2013, when the child had an accident at home that damaged his one remaining kidney. That kidney is now only functioning at 38%, causing significant health problems and future health risks.

In addition, the family indicates that the boy was born without a fully functioning vas deferens, which means that it will be either extremely difficult or impossible for him to have children and he may not have any normal male sexual functionality.

“G.K. has no family history of any of the conditions from which he suffers. Angela and Bryan Kutzer both have both of their kidneys, and upon information and belief so does every other family member,” the lawsuit notes. “In addition, G.K. has an older brother who was born healthy and vibrant after Ms. Kutzer carried him for a full-term pregnancy during which she does not believe she ingested any Zofran.”

The complaint joins a growing number of Zofran birth defect lawsuits filed recently against GlaxoSmithKline, alleging that the drug maker has known about the risks associated with use of the nausea medication during the first trimester of pregnancy, yet failed to adequately warn women or the medical community.

Zofran (ondansetron) is a widely used prescription medication for treatment of nausea and vomiting. Although the FDA has only approved Zofran for use among cancer and surgery patients, it is commonly prescribed “off-label” to pregnant women for treatment of morning sickness or pregnancy-associated nausea and vomiting.

The Kutzers and other families allege that GlaxoSmithKline knew or should have known about the potential Zofran first trimester pregnancy risks, yet illegally marketed the drug for use among pregnant women.

Most of the lawsuits filed in courts throughout the U.S. claim that children have been born with various heart defects from Zofran, including atrial septal defects (ASD), ventrical septal defects (VSD). A number of complaints also allege that children suffered cleft lip or cleft palate from Zofran use during the first trimester.

The Kutzer family accuses GlaxoSmithKline of negligence, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, strict product liability, unfair trade practices, and loss of consortium. The lawsuit seeks compensatory damages for medical expenses, loss of consortium, and legal expenses.

Last month, GlaxoSmithKline filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking to centralize all Zofran cases before one judge for coordinated pretrial proceedings.

If the request is granted, the Kutzer lawsuit will be consolidated with other cases for discovery and a series of “bellwether” trials designed to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the Zofran litigation.

If GlaxoSmithKline fails to reach Zofran birth defect settlements or otherwise resolve the litigation, the drug maker could face dozens of individual trials in courts throughout the U.S.