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Zofran Caused Alabama Infant’s Heart Defects, Parents Claim

While more than 60 Zofran cases were recently consolidated and sent to Boston, more and more Zofran lawsuits continue to surface, including a recent case in which Alabama parents claim Zofran caused their infant’s severe heart defects.

On September 18, the parents, who filed a lawsuit at the United States District Court for the Northern District of Alabama, Southern Division, claim that the mother (plaintiff) was prescribed Zofran by her physician in 2011, after she began to experience extreme morning sickness. During the first eight weeks of her pregnancy, the mother states that she was given Zofran via an IV. Afterwards, she took the pill form of Zofran for a month.
mother with baby

When her son was born, he immediately showed signs of distress shortly after delivery, with a blue tint to his lips and skin. The infant’s medical team transferred the baby to a larger medical hospital that could help him more. The baby was kept in the new facility for two months, where he was diagnosed with “significant heart defects, specifically, three separate holes in his heart.” 

Since the baby wasn’t yet old enough for surgery, physician waited until 2015, when they determined he was old enough and strong enough to withstand an invasive treatment procedure. The surgery repaired a severe atrial septal defect, a heart defect that divides the heart’s upper chambers into the left and right atrium.

Zofran Lawsuit Against GlaxoSmithKline

The parents of the child sued GlaxoSmithKline (GSK), the makers of Zofran. Per court documents, the plaintiffs claim that they were never told of the risks of birth defects associated with taking Zofran, and if they had known, the mother would have never agreed to take them.

According to the mother,

“Zofran would never have become the most prescribed morning sickness drug in the United States, and I would never have taken it, if GSK had not misleadingly marketed the drug as a safe and efficacious treatment for morning sickness.”

The plaintiffs also assert that GSK knew beforehand the dangers of pregnant women taking the medication, yet did nothing to prevent it from being prescribed. To back up their claim, the plaintiffs cited a number of studies and reports on Zofran that were given to the FDA by physicians, scientist, and researchers. These reports began to appear as far back as 1992, yet GSK continued to market Zofran to pregnant women, according to the complaint.

Furthermore, the plaintiffs claim that although GSK knew of the risks, they remained silent about it due to the monetary gain the company was receiving by marketing Zofran as off-label use for morning sickness. There is no mention on the medications warning label of the risks of birth defects, although numerous studies have confirmed that there is a possibility of infants developing a myriad of different defects associated with Zofran.

There was no indication as to the amount of damages the plaintiffs are seeking.

If You Took Zofran While Pregnant

Keep in mind that if you took Zofran while pregnant and your baby developed a birth defect associated with the medication, you have the legal right to file a Zofran lawsuit against the responsible party. Even though more than 60 Zofran cases have already been consolidated, that in no way impact other parent’s right to file their own lawsuit. Birth defects can result in a plethora of medical treatments and expenses, typically more than the average family can afford. An experienced Zofran attorney can help you obtain compensation for pain, suffering, medical expenses, and more.


U.S. District Court for the Northern District of Alabama, Southern Division, Case Number 2:15-cv-01638-RDP.