GlaxoSmithKline is facing another Zofran lawsuit, with a couple alleging that the anti nausea medication caused their child to be born with birth defects.

The couple claims that in direct result of Zofran, their son will have to contend with multiple birth defects that will impair him for the rest of his life.

Plaintiff couple Amanda P. and Josh P. are filing this lawsuit on behalf of their son, B. P., who was born with multiple congenital birth defects. The child was born in 2014 with several cardiac defects, pyloric stenosis and inguinal hernias. B.P. has no family history of any of these birth defects, giving the parents no reason to expect problems upon his birth.

Due to his birth defects, B.P. has needed a cardiology specialist, multiple surgeries, and intense medical care since his birth. He will most likely require intense medical care, and is likely to need more surgeries in the near future.

According to the lawsuit, the boy was exposed to a generic version of Zofran during the early stages of his mother’s pregnancy, after she was prescribed the drug to treat morning sickness.

At no point during her Zofran prescription did GlaxoSmithKline warn her or her physician of birth defect risks or provide any relevant studies. Amanda insists that she never would have taken Zofran, if she had known the risks of birth defects.

Overview of Zofran Birth Defects Complications

Zofran was approved by the FDA in 1991 to be used a nausea remedy for patients undergoing chemotherapy and radiation treatment. Soon after its release, doctors began prescribing Zofran for the off-label purpose of treating morning sickness.

Despite never being clinically tested for morning sickness, GlaxoSmithKline began marketing the drug as an effective nausea treatment to pregnant women. The drug company’s marketing campaign worked, as Zofran became the most popularly prescribed morning sickness treatment drug in the 2000s.

Women would most commonly request this medication during the early stages of their pregnancies, when hormone fluctuations are a common occurrence and morning sickness is often rampant.

While the drug is well known for being successful in its nausea and vomiting prevention, it was soon discovered that Zofran may have major side effects to unborn children.

Due to the false advertising claims of GlaxoSmithKline, pregnant women had no way of knowing they were exposing their children to potential birth defects. So for being allegedly responsible for manufacturing, selling, distributing, and marketing a dangerous drug, Amanda and Josh are suing GlaxoSmithKline.

The charges include negligence, false advertising, concealing information, and misrepresenting a product.

This Zofran lawsuit is Amanda P. and Josh P. v. GlaxoSmithKline LLC, Case No. 2:15-cv-01904-TMP, in the U.S. District Court of Northern Alabama, Southern Division.