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

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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.

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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.

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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.

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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.

To learn more about cleft palate and the condition’s link to Zofran, click here.

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.

For more information, visit “Zofran Side Effects: Heart Defects.”

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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.

Visit our Zofran FAQ for answers to the most commonly asked legal questions. On our Zofran News page, you’ll find regular updates on breaking developments affecting the Zofran litigation.

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.

Latest Zofran News & Updates

Laurence P. Banville - Zofran Product Lawyer
Zofran is a drug that has been used by women experiencing pregnancy related nausea without them actually knowing the negative effects this drug has on unborn children. Below you will find regular updates about lawsuits being brought to court over the wrong use of Zofran in pregnant women.

September 26, 2017 – Scientists Find A New In-Utero Treatment Could Possibly Prevent Cleft Palate From Occurring

The Centers for Disease Control and Prevention states that cleft palate is one of the most common birth defects in the world with about 2,650 babies affected in the U.S. each year. Recently a group of scientists from the University of Utah Health was planning to study 2 sets of genes and how they affect the formation of teeth. During their research, they discovered these genes also work to ensure the palatal shelves grow and develop during fetal formation. From this discovery and research, they were able to create an in-utero treatment that could prevent the deformity from occurring. More research and testing must be completed but their current results look promising.

August 16, 2017 – Zofran Lawsuit Plaintiffs Request Release Of GSK Documents

Plaintiffs involved in Zofran lawsuits that have been filed against GSK (GlaxoSmithKline) over birth defects are requesting that the federal courts overseeing the MDL order the company to turn over regulatory files from the United Kingdom, Canada, and Japan. The families who have filed these lawsuits say that these documents will show that GSK failed to disclose to U.S. regulators that Zofran could cause birth defects.  A similar discovery request had been made previously but it was denied. The judge said in that instance that if the plaintiffs could make a request for correspondence with health officials from specific countries that mentioned problems with pregnant women taking Zofran, they could be more successful.

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July 26, 2017 – Risk Of Birth Defects Increase With Some Antibiotics

Canadian researchers followed over 100,000 mothers of babies born in Quebec from 1998 – 2008 and tracked their use of antibiotics during the first trimester, as well as birth defects through the first year of the child’s life. The results of this large study were published in the British Journal of Clinical Pharmacology. These results indicate that certain antibiotics in the class called quinolones are dangerous and should be avoided during pregnancy due to the risk of birth defects in the unborn baby.

June 30, 2017 – Risk Of Birth Defects Linked To Obesity In Pregnancy In New Research

Swedish researchers conducted a study using data from over 1.2 million live births in Sweden between the years of 2001 to 2014. The research links the risk of birth defects to obesity in pregnancy.  In the British Medical Journal, researchers urged women to attain a healthy weight prior to conceiving children. Some of the possible risks of severe obesity during pregnancy include stillbirth, preeclampsia, and diabetes. Obesity is considered a growing global health problem.

May 31, 2017 – 25% Of Birth Defects Related To Zika Were Born In New York

On Thursday, May 25th, city health officials announced that 25% of the babies born in the U.S. with Zika-related birth defects were born to women in New York City. Almost 1,500 pregnant women were identified as infected with Zika and 64 babies were born with related birth defects. 16 of those babies were born in New York City. Last year the health commissioner said that the city took unprecedented action to raise awareness of the risks of Zika transmission. Zika is no longer making news like it was last year but it is still important for people traveling, especially pregnant women, to take proper precautions. This news was released around the same time as a new study was published in BMJ which stated that only ⅕ of birth defect cases are explained. This brings the need for more research in the area back into the public’s eyes.

April 25, 2017 – Fraud Claims In Zofran Lawsuit Will Stay

On Monday, April 24, a Massachusetts judge ruled that the fraud claims in the Zofran multidistrict litigation can remain. The judge said that the fraud claims against GlaxoSmithKline about the drug’s labeling are sufficiently specific despite finding the allegations against the marketing campaign too broad. The MDL is comprised of lawsuits similarly alleging that the manufacturers of the anti-nausea drug misrepresented the safety of Zofran by marketing it to pregnant women, a group of people that the drug had never been tested on for safety. 

March 29, 2017 – New Device Could Change Drug Testing For Different Genders

An article in National Geographic reported this month that scientists have a device in a laboratory in Chicago that has, for the first time, replicated a full menstrual cycle. The device is called EVATAR and was created to help scientists understand how medications impact women. It is only recently that drugs were even tested on women at all which has caused problems when doctors assumed that medications will have the same effect on women as men. This device could make it easier to test drugs, such as Zofran, in a system that mimics a woman’s body. Other labs have created other “organs on a chip,” even a working model of a human placenta which was developed by an endocrinologist at the University of Pennsylvania.

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February 28, 2017 – Some Women Who Were Prescribed Zofran Turn To Marijuana

The New York Times recently published a piece as a follow-up to a previous publication which stated that the number of pregnant women who use marijuana is increasing. The follow-up piece used only a few names due to the sensitive nature of the topic and many women’s desire to remain anonymous. Of the five women interviewed two had decided to use marijuana rather than the off-label prescription they would have received for Zofran. Some of the women felt they were out of options to manage their pain or nausea, while others feared what using prescription drugs such as Zofran could do to their unborn children. Each of the women interviewed expressed great concern for their child and several had conducted their own research into marijuana use prior to making a decision.

January 23, 2017 – Plaintiffs In Zofran MDL Fight Motion To Dismiss Fraud Allegations

Plaintiffs in the Zofran MDL housed in Massachusetts filed a response to the defendant GSK’s argument that the fraud allegation should be dismissed. The master complaint states that GSK aggressively and illegally promoted Zofran off-label for morning sickness and misrepresented the safety risks to pregnant women. GSK has stated in its dismissal motion that the plaintiffs failed to include details such as who, what, when, where, and why in their complaint. Plaintiffs responded that those details will be set out in the future.

December 15, 2016 – Judge Saylor Refused To Throw Out 5 Zofran Lawsuits

GSK has been attempting, since September, to get five Zofran birth defect lawsuits dismissed for not meeting discovery deadlines. The families who filed the suits claimed that in order to obtain medical records they needed more time, but they have since filed all the necessary documents. Presiding Judge F. Dennis Saylor has stated “dismissal is not appropriate under the circumstances” and has allowed the cases to proceed. The litigation has been moving very slowly but has made progress. Plaintiffs are hopeful for more significant progress next year, despite no trial date being set yet.

November 10, 2016 – GSK Tells Court Fraud Claims In Zofran MDL Should Be Dismissed

Zofran manufacturer GlazoSmithKline asked a Massachusetts federal court to dismiss the fraud claims the company faces in the Zofran MDL because they say the suits do not outline the details of the alleged misconduct. GSK specifically asked to dismiss claims of negligent misrepresentation, fraudulent misrepresentation, and concealment and violation of state consumer protection laws. Plaintiffs in the MDL claim that GSK marketed and promoted Zofran as a safe and effective treatment for morning sickness from pregnancy when the drug was not FDA-approved for that use.

October 20, 2016 – GSK Adds To Zofran Warning Label To Avoid Liability

According to Consumer Advocacy News, in an effort to avoid liability, GlaxoSmithKline has added to the warning label of Zofran to include a warning about the link between taking Zofran while pregnant and an increased risk of birth defects in babies. There are currently over 300 Zofran lawsuits consolidated in Massachusetts, many of which allege that GSK was negligent in failing to warn consumers of the risk of birth defects when taken during pregnancy. Plaintiffs claim the company knew about the risks long before the recent label change and many others allege that GSK illegally promoted the drug for use in pregnant women despite it never being tested for safety in that group.

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September 16, 2016 – Woman Files Wrongful Death Suit After Using Zofran During Pregnancy

On June 8 a woman who had used Zofran during her pregnancy filed a wrongful death lawsuit on behalf of her minor children. The plaintiff alleges the anti-nausea drug caused her twin babies to develop severe birth defects, which ultimately claimed the life of one of her young children. The surviving baby was diagnosed with heart defects, which will necessitate surgeries in the future as well as further medical treatment. The plaintiff’s case is one of over 250 cases alleging that the drug caused birth defects to fetuses exposed to it through their mothers in the womb.

August 18, 2016 – Travel Warning Issued By CDC Due To Zika Outbreak In Florida

On August 1st the CDC released a travel warning for pregnant women and their partners to avoid an area of Florida north of Miami where cases of locally contracted Zika virus were identified. Four locals were found to have contracted the virus after being bitten by local mosquitoes. Zika is especially dangerous for pregnant women because the disease is known to cause microcephaly, or a shrunken head and underdeveloped brain, among other serious side effects in fetuses. Efforts are underway to control the mosquito population. Meanwhile, some U.S. researchers are hopeful that some good can come about from the Zika scare by way of raised awareness and additional funding for birth defect research.

April 7, 2016- Direct Zofran Lawsuit Filing In Multidistrict Litigation No. 2657 Permitted

The Honorable F. Dennis Saylor IV, who is supervising lawsuits involving Zofran MDL number 2657, has issued an order that will help simplify the usual lawsuit filing procedure for people who want to file and join the MDL. The order will help potential plaintiffs who want to file Zofran lawsuits on their own, to do so directly. This means that they can skip the usual process of filing in local federal courts and then later transferring their case.

March 16, 2016- Document Submitted For Zofran Lawsuit Protective Order

A document has been submitted that serves as a proposed court order to keep certain documents pertaining to Zofran lawsuits confidential. The document was submitted in the District Court of Massachusetts, as a means to prevent sensitive information from being shared publicly, as well as specifying the consequences of releasing such confidential information.

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