While Zofran has been proven effective as a morning sickness medication, recent research studies have also determined that it can often cause significant Zofran birth defects.

Consequently, there has been an alleged steady rise in the number of Zofran birth defect lawsuits in the U.S. as growing public awareness sends more and more families of infants with birth defects to challenge the manufacturer, GlaxoSmithKline, with legal action.

How Zofran Became a Leading Morning Sickness Medication

Zofran was approved by the US Food & Drug Administration in 1991. Initially, the drug was designed and cleared for the treatment of nausea and vomiting caused by potent cancer treatments like chemotherapy.

It was never, and is still not, approved as a morning sickness medication. But no sooner had Zofran been released onto the US market than physicians across the country began using it to treat the nausea and vomiting of pregnancy.

Before Zofran came along, there weren’t any drugs approved to treat morning sickness in the US. Bendectin, the last nausea medication approved for use during pregnant, was withdrawn from the market way back in 1983.

Then Zofran came along.  But it wasn’t approved to treat morning sickness.  So how did it become such a popularly prescribed morning sickness drug?

One theory to explain Zofran’s unprecedented popularity is that GlaxoSmithKline marketed Zofran to doctors as a safe and effective morning sickness drug, which is illegal.

While doctors have every right to prescribe drugs off-label, pharmaceutical manufacturers are only allowed to promote their products for approved uses.

GlaxoSmithKline, however, had been allegedly telling obstetricians and gynecologists to try Zofran in their pregnant patients, going so far as to imply that Zofran side effects would not affect early fetal development.

According the Justice Department, the company had even set up a system of illegal kick-backs to compensate physicians who sold a lot of Zofran.

In 2011, the U.S. Government took GlaxoSmithKline to court, in part for unlawfully promoting Zofran. After a year-long legal battle, the company’s attorneys reached a settlement agreement, but still GlaxoSmithKline did not have to accept any liability for its alleged off-label promotion of Zofran.

Despite never claiming responsibility, the company agreed to pay the government $3 billion. It remains the largest settlement for alleged health care fraud in US history.

Zofran Birth Defects Include Heart Defects

Hundreds of families have filed Zofran birth defects lawsuit against GlaxoSmithKline, claiming Zofran side effects cause birth defects. Despite having never been approved for use during pregnancy, Zofran is currently the top-selling morning sickness drug in the US.

More than 1 million women are prescribed the drug every year, many in their first trimester, when developing fetuses are most susceptible to harm.

One of these Zofran birth defects lawsuits was filed by plaintiff Christine R. who alleges that her prenatal exposure to the generic equivalent of Zofran caused her son to be born with multiple congenital defects, including congenital heart defects such as Still’s murmur and pulmonary flow murmur.

Another woman who was prescribed Zofran to alleviate morning sickness symptoms during pregnancy filed her Zofran birth defects lawsuit after her son was born with severe heart defects and club foot for which he had to undergo surgery at just two months.  Plaintiff Janay W. claims her son’s problems were due to her use of Zofran during pregnancy.

Both Christine and Janay assert that they would have never used Zofran had they been aware of evidence linking the nausea medication to birth defects.

If you or someone you know took Zofran while pregnant and their child suffered birth defects, contact a Zofran birth defects lawyer immediately for a free initial consultation.