13 August 2015

North Dakota Parents Say Zofran To Blame For Son’s Missing Kidney

In a new lawsuit, filed July 27, 2015, a family from Bismarck, North Dakota claims that prenatal exposure to the anti-nausea drug Zofran caused their son’s “debilitating” kidney defects.

This may be the first claim against GlaxoSmithKline, the international pharmaceutical conglomerate behind Zofran, to be filed in relation to kidney, or “renal” abnormalities. As the Zofran litigation grows, the majority of complaints have named congenital heart defects, a category of anomalies linked to prenatal Zofran exposure by at least two major studies.

The North Dakota family’s claim was filed in the US District Court of North Dakota, Southwestern Division. Registered under case number 1:15-cv-00102-CSM, a copy of the court documents can be found below:

View Complaint: 1:15-cv-00102-CSM

Exposure To Zofran Caused Numerous Kidney Defects, North Dakota Family Says

Plaintiff claims that she was prescribed Zofran early in the first trimester of pregnancy. She continued to take the drug, intended as an “off label” morning sickness treatment, throughout her pregnancy, both in pill form and intravenously.

Her son, named G.K. in court documents, was born in 2007. But it would take another 6 years, the family writes, for them to learn of their child’s congenital defects.

In October 2013, G.K. was injured at home and rushed to the emergency room. There, a diagnostic examination of the injury, which involved a kidney, revealed that G.K. was missing the other kidney. According to the complaint, “the only kidney G.K. was born with, which was injured in the accident, was significantly damaged.” G.K. was airlifted to a hospital in Minneapolis, where he received “extensive treatment.”

Born With A Missing Kidney, & No Hope For A Transplant

G.K.’s alleged condition, known to the medical community as congenital unilateral renal agenisis, is particularly severe.

Agenisis is not synonymous with atresia, which refers simply to the absence or abnormal positioning of an organ. Unlike atresia, agenesis suggests an underlying cause: the organ failed to develop from earlier cellular structures, because those earlier structures were themselves absent.

In this case, G.K. was born not only missing a kidney, but also missing the “connective tissues” necessary to support a kidney transplant. Those tissues, the family’s complaint suggests, would have developed from the very same cellular structures as the kidney itself.

According to his parents, G.K. belongs to a small group of children with unilateral renal agenesis who are also missing a vas deferens, the tube or “duct” that carries sperm from the testicles to the urethra. While little research has been conducted to investigate the association between both conditions, German researchers found that among 105 patients, 74% of males missing one vas deferens were also missing a kidney.

G.K.’s lack of a vas deferens, Plaintiffs claim, means he may never be able to “have any normal male sexual function at all.”

As a result of his missing kidney, G.K.’s “current health situation [is] debilitating and […] grave,” report his parents. His existing kidney, they write, functions only at 38% of its potential, posing a “serious threat” to his “health and enjoyment of life.”

According to the family’s doctors, the mildest aggravation presents a significant risk of injury or even death. An avid soccer and basketball player prior to his diagnosis, G.K. has been told that he can never play sports again, his parents say.

Like all plaintiffs to join the Zofran litigation, G.K.’s parents claim the anti-nausea drug caused their son’s severe congenital births.

Zofran Litigation Update: Are Lawsuits Heading Toward MDL?

This newest Zofran lawsuit is now one among many.

In Federal Courts across the nation, 33 lawsuits allege that GlaxoSmithKline fraudulently promoted Zofran as a “safe” morning sickness treatment, while concealing evidence of the drug’s link to major birth defects.

On July 6, 2015, GlaxoSmithKline petitioned the Judicial Panel on Multidistrict Litigation (JPML), requesting that all Federally-filed Zofran claims be consolidated in the US District Court for the Eastern District of Pennsylvania, close to the company’s headquarters in Philadelphia.

Almost 20 Plaintiffs filed briefs in response, agreeing in principle to GlaxoSmithKline’s motion to consolidate, but contesting the company’s choice of venue. Several other Federal Courts have been suggested, but a reply submitted by GlaxoSmithKline’s counsel on August 5 maintains that the Eastern District of Pennsylvania is most appropriate.

It remains to be seen whether the JPML will opt for GlaxoSmithKline’s chosen venue, one of the courts suggested by Plaintiffs, a court of its own choosing or decide not to consolidate Zofran claims at all. A hearing on the matter is scheduled for October 1, 2015.

To learn more about what consolidation and Multidistrict Litigation might mean for Zofran birth defect lawsuits, click here.