Top Class Actions’s website and social media posts use affiliate links. If you make a purchase using such links, we may receive a commission, but it will not result in any additional charges to you. Please review our Affiliate Link Disclosure for more information.

zofran-baby-nicuParents of a daughter born with congenital heart defects have filed a Zofran lawsuit, attributing those birth defects to GlaxoSmithKline’s anti-nausea drug.

Plaintiffs Christina M. and Daniel P. of Alabama are suing on behalf of their minor daughter, referred to as “A.P.” in the Zofran birth defect lawsuit. Christina says that during the first trimester of her pregnancy with A.P., she began taking Zofran as a treatment for morning sickness.

The parents claim that in 2014, A.P. was born with an atrioventricular canal defect and associated complications that included acute respiratory failure, heart failure and other injuries. They allege that following birth, A.P. had to undergo extensive surgery to repair her congenital heart defects and that she will likely have to undergo more surgeries in the future.

Christina and Daniel now argue that A.P.’s birth defects were directly caused by the Zofran that Christina took early in pregnancy. They say they were unaware of any risks of birth defects associated with Zofran, and had they known there was a possible risk associated with taking Zofran, Christina would not have taken that drug and A.P. would not have been born with birth defects.

Zofran Birth Defects Overview

Zofran is manufacturer GlaxoSmithKline’s brand name for the anti-nausea drug known generically as ondansetron. Since first entering the market in 1991, Zofran has been approved by the FDA as a treatment for nausea associated with only chemotherapy, radiation therapy, or surgery. Christina and Daniel note in their Zofran lawsuit that the FDA has never approved the drug as a treatment for morning sickness.

The plaintiffs claim that since as far back as the mid-1980s, GSK was aware that using Zofran during pregnancy could expose the fetus to the drug. In the Zofran lawsuit, they state that early studies on animals showed evidence of “fetal toxicity, premature births, intrauterine fetal deaths, and impairment of ossification.”

The parents allege that GSK received reports of possible Zofran birth defects as early as 1992, and that since then GSK has received over 200 such reports. They also cite three more recent epidemiological studies that show a higher incidence of congenital heart defects in babies whose mothers took Zofran during pregnancy.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Lawsuits

The plaintiffs are accusing GlaxoSmithKline not only of failing to warn about the possibility of Zofran birth defects but also of actively promoting Zofran for use as a treatment for morning sickness even though the FDA never approved it for that use.

The couple states that GSK failed to respond to reports of Zofran birth defects in a manner consistent with federal laws and regulations. As early as 1999, the FDA had admonished GSK for promoting Zofran in a manner that was “false or misleading.”

The plaintiffs also refer to a 2012 settlement between GSK and the U.S. Justice Department that in part resolved allegations that GSK had misrepresented the safety and efficacy of Zofran in pregnant women, and that the company had compensated health care providers in exchange for prescribing Zofran.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

The Zofran Birth Defect Lawsuit is Case No. 5:15-CV-01914 in the U.S. District Court for the Northern District of Alabama.

Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The birth defect attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual Zofran lawsuit or Zofran class action lawsuit is best for you. [In general, Zofran lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.

Learn More

Get Help – It’s Free

Join a Free Zofran Birth Defects Class Action Lawsuit Investigation

If you or someone you know took Zofran while pregnant and had a baby with a birth defect, you or this person may have a legal claim. See if you qualify by filling out the short form below.

A Zofran birth defect attorney will contact you if you qualify to discuss the details of your potential case at no charge to you.

Oops! We could not locate your form.

We tell you about cash you can claim EVERY WEEK! Sign up for our free newsletter.


Please note: Top Class Actions is not a settlement administrator or law firm. Top Class Actions is a legal news source that reports on class action lawsuits, class action settlements, drug injury lawsuits and product liability lawsuits. Top Class Actions does not process claims and we cannot advise you on the status of any class action settlement claim. You must contact the settlement administrator or your attorney for any updates regarding your claim status, claim form or questions about when payments are expected to be mailed out.