The parents of a child born with birth defects filed a Zofran birth defects lawsuit against drug giant GlaxoSmithKline, alleging the company’s drug caused their child’s birth defects.

Plaintiffs Kayce H. and Josh H. of Northport, Alabama filed the lawsuit in October on behalf of themselves and their child, C.H. During the first and second trimesters of her pregnancy, Kayce H. was prescribed the anti-nausea drug Zofran.

Even before C.H’s birth, ultrasound imaging revealed serious birth defects. This included malformations to the urethra. According to the their Zofran lawsuit, the family had no history of genetic problems which could cause birth defects like these, and C.H. will require surgical correction of his birth defects.

The Zofran lawsuit alleges that GlaxoSmithKline knew, or reasonably should have known, of the risk of birth defects associated with Zofran. To back this assertion, the Zofran lawsuit asserts that animal and human studies conducted back in the 1980s by GlaxoSmithKline showed that Zofran’s active ingredient could cross the placental barrier and cause birth defects in mammals.

Additionally, the Zofran lawsuit states that as early as 1992 reports started coming in that patients taking Zofran had given birth to children with serious birth defects. The lawsuit also asserts that GlaxoSmithKline engaged in illegal, off-label marketing of the drug.

Off-label marketing is the practice of promoting a drug beyond its FDA-approved purpose. When a drug is approved for use in the U.S., the FDA requires thorough testing for safety and efficacy. A drugmaker is legally required to submit separate testing for each use of the drug and may only advertise the drug for the approved purpose.

Doctors are allowed to prescribe drugs off-label based on their judgment as medical research sometimes moves faster than the FDA approval process. And this Zofran lawsuit alleges that GlaxoSmithKline engaged in this activity.

To back this assertion, the Zofran lawsuit cites the 2012 guilty plea from GlaxoSmithKline to charges that the company had engaged in off-label marketing. Zofran has only been approved by the FDA to treat extreme forms of nausea, such as those associated with chemotherapy and radiation treatments.

It was never tested or approved for use in pregnant women to mitigate morning sickness. The Zofran lawsuit alleges that the company promoted the drug for this off-label use, which led Kayce H. to take the drug during her pregnancy, and to C.H. developing serious birth defects from Zofran exposure before his birth.

The family’s Zofran lawsuit seeks to recoup the cost of medical care for C.H, as well as compensation for pain and suffering by the family. The Zofran lawsuit also seeks legal fees and other costs related to the alleged Zofran birth defects.

The Zofran birth defect lawsuit is Case No. 1908, filed in the United States District Court for the Northern District of Alabama, Western Division.