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Parents Say Nausea Drug Zofran Causes Birth Defects

In more than 260 lawsuits, families say GlaxoSmithKline’s anti-nausea drug Zofran causes birth defects, including cleft palate and congenital heart abnormalities.

Zofran, a powerful anti-nausea drug manufactured by GlaxoSmithKline, has now been linked to an increased risk for major birth defects, including cleft palate and congenital heart defects.

While this litigation is currently closed, learn more about related cases, including Elmiron lawsuits from our attorneys:

Litigation Status: Inactive
Accepting Clients: No
Content Author: Laurence Banville
Edited By: Emily Smith
Published: 0707/2222/15151515
Fact checked on: 0707/2222/15151515
"The lawyers that form this alliance truly work on these cases and often take leadership positions on the steering committees that litigate them." - Laurence Banville

Zofran Birth Defect Lawsuits

In a series of major epidemiological studies, researchers from across the globe have identified a two to four times increase in the rate of cleft palate, atrial septal defect, ventricular septal defect and atrioventricular septal defect among babies exposed to the common “off label” morning sickness treatment prenatally.

Now, a wave of Zofran birth defect lawsuits have been filed against GlaxoSmithKline. In their complaints, families claim that the company unlawfully marketed Zofran, which has never been approved for use during pregnancy, as a “safe and effective” morning sickness treatment. But their allegations go much further. Plaintiffs say that GlaxoSmithKline has concealed mounting evidence of Zofran’s link to birth defects for more than two decades.

Lawyers Fighting For Parents & Birth Defect Survivors

Banville Law has joined an alliance of plaintiffs’ attorneys dedicated to pursuing justice for families who believe they were harmed by prenatal exposure to Zofran.

Led by Monheit Law’s Michael Monheit, Esq., an attorney with more than 20 years of trial experience, our coalition of personal injury lawyers is currently offering free consultations to parents and birth defect survivors.

Banville Law’s Zofran lawyers believe that everyone deserves experienced legal counsel, no matter your personal circumstances. That’s why we always offer our services on a contingency-fee basis: you don’t pay anything until we win a court award or settlement in your favor.

Learning more about the ongoing Zofran litigation and your own legal options is free, too.

What Is Zofran?

Zofran (active ingredient: ondansetron) has been FDA approved for the treatment of severe nausea and vomiting in three specific types of patient:

  • cancer patients undergoing chemotherapy
  • cancer patients undergoing radiation therapy
  • patients undergoing surgical anesthesia

While Zofran’s complete mechanism of action remains unclear, the medical community believes that ondansetron “short circuits” a particular chemical pathway causing nausea and vomiting.

When the gastrointestinal tract is irritated by a potentially toxic substance, it releases large quantities of a neurotransmitter called serotonin. Serotonin then travels through the body to the brain, where it attaches to a special receptor that triggers the feeling of nausea and the involuntary response of vomiting.

Zofran gets to that special receptor first, filling it inadequately, but blocking any serotonin that might attach. As a result, clinical trials have found that Zofran significantly lowers nausea and vomiting in some patients. But those clinical trials only involved patients undergoing cancer treatments and surgical anesthesia.

Zofran’s safety during pregnancy has never been demonstrated. In fact, GlaxoSmithKline has never even studied its effects on pregnant women or their unborn babies. Now a growing body of medical research has suggested that ondansetron may pose substantial risks for fetal development.

America’s Morning Sickness Best-Seller

Unfortunately, a thirty-year drought in which no medication was FDA-approved for the nausea and vomiting of pregnancy opened GlaxoSmithKline’s drug up to another, extremely lucrative market.

Soon after Zofran’s initial approval in 1991, physicians across the country found a new, unapproved use for the potent anti-nausea medication: treating morning sickness in pregnant women. Millions of unborn children have now been exposed to Zofran prenatally.

Recent studies have suggested that Zofran has become America’s leading prescription for the nausea and vomiting experienced by as many as 90% of all pregnant women; estimates indicate that more than 1 million Zofran prescriptions are written for morning sickness every year. A study published in the Journal of Clinical Outcomes Management found that patients were 5 times more likely to be prescribed Zofran’s active ingredient, ondansetron, for unapproved uses than they were to be prescribed any other “industry standard” nausea treatment. In other words, ondansetron is the “industry standard,” no matter what underlying condition is causing a patient’s nausea.

But whether Zofran is being prescribed for unapproved or approved uses, ondansetron is big business for Glaxo.

Did GlaxoSmithKline Unlawfully Promote Zofran As A Morning Sickness Treatment?

Physicians are allowed to prescribe drugs “off label,” for unapproved purposes. It’s actually extremely common; in 2006, public health researchers at Dartmouth, Stanford and MIT found that one out of every five drugs prescribed in America was being used to treat an “off label” condition. More often than not, “off label” prescription has dubious scientific support, in regard to both safety and efficacy, but there are currently no regulations limiting physicians’ ability to prescribe drugs for unapproved purposes.

It is, however, unlawful for pharmaceutical manufacturers to promote their drugs “off label.” And in 2012, the US Department of Justice charged GlaxoSmithKline for doing just that. In what would eventually become the largest case of alleged healthcare fraud in US history, the Federal Government claimed that the company had been marketing several drugs, including Zofran, directly to doctors for “off label” use.

Announcing the case’s resolution on July 2, 2012, the US DOJ wrote that a $3 billion settlement agreement “resolve[d] allegations that GSK promoted certain forms of Zofran, approved only for post-operative nausea, for the treatment of morning sickness in pregnant women.”

GlaxoSmithKline continues to deny any wrongdoing in relation to Zofran, but Plaintiffs in Zofran birth defect lawsuits are insistent, claiming the company’s alleged off label promotion placed a drug with potentially devastating effects into the hands of unsuspecting pregnant women everywhere.

Studies Link Drug To Increased Risk Of Birth Defects

On the heels of the Federal Government’s allegations, researchers around the world began to investigate Zofran’s potential effects on unborn babies.

So far, their results have been more than troubling.

Cleft Palate

In 2012, researchers at Harvard Medical School and Boston University’s Slone Epidemiology Center reviewed more than 10,000 pregnancy records, finding that women who took ondansetron during the first trimester were 2.37 times more likely to deliver babies with a cleft palate.

Congenital Heart Defects

In 2013, a team in Denmark looked at every Danish birth record filed between 1997 and 2010. They found that women who were prescribed ondansetron during early fetal development were 60% more likely to have children a congenital heart defect and:

  • 2.1 times more likely to deliver babies with an atrial septal defect
  • 2.3 times more likely to deliver babies with a ventricular septal defect
  • 4.8 times more likely to deliver babies with an atrioventricular septal defect

Swedish researchers would repeat the study in 2014, reviewing every birth record logged in Sweden between 1998 and 2012. Their findings were strikingly similar to those published the year before in Denmark: women exposed to Zofran’s active ingredient during the first trimester were 62% more likely to have babies with a cardiovascular defect and 2.05 times more likely to deliver children with cardiac septal defects, a category that includes atrial, ventricular and atrioventricular septal defects.

Plaintiffs Accuse GlaxoSmithKline Of Failing To Warn Public

In at least 15 filed lawsuits, parents claim that prenatal exposure to Zofran caused their unborn children to develop congenital defects. Many of these Plaintiffs name heart defects, including atrial and ventricular septal defects, in their complaints, but claims have also been filed in relation to cleft palate and other abnormalities.

These families allege that GlaxoSmithKline unlawfully promoted Zofran as a morning sickness treatment while concealing mounting evidence of Zofran’s potential to increase the risk for birth defects for over 20 years.

Contact Birth Defect Lawyers

More families may be eligible to file claims against GlaxoSmithKline. Legal experts expect numerous Zofran birth defect lawsuits to be filed in the coming months. Although it is unlikely that the Zofran litigation will lead to class action, an increase in lawsuits may raise the likelihood of Zofran settlements in the future.

Along with a multi-state alliance of plaintiffs’ attorneys, we are offering free consultations to women who were prescribed Zofran as an “off label” morning sickness treatment and delivered children with major birth defects.

We’re here to help. That’s why our services are always offered on a contingency-fee basis: you don’t pay a thing until we secure compensation in your case.

Finding more information on your legal options comes at no cost as well.

Continue Reading: Thousands Of Blood Thinner Patients Join Xarelto Litigation

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