Timeline of the Zofran Lawsuit

Zofran has U.S. Food and Drug Administration (FDA) approval for use in cancer patients undergoing chemotherapy and radiation treatment. It is designed to prevent nausea and vomiting, which is a common side effect of these treatments. Zofran is not FDA approved for use by pregnant women, however, the medication has been aggressively marketed to OB-GYN physicians as a safe and effective treatment for morning sickness.

It is illegal for a pharmaceutical company to market medications for uses not approved by the FDA.

It is not unlawful or unusual for doctors to prescribe drugs for off-label purposes when they are believed to be safe. It is illegal, however, for a pharmaceutical company to market medications for uses not approved by the FDA. GSK has been accused of this behavior before. In 2012, the company admitted guilt to charges that included marketing drugs for unapproved purposes and paid out over three billion dollars in fines and restitution.

As a result of all of these prescriptions for pregnant women, there have been hundreds of reported birth defects related to Zofran, including serious heart complications, cleft palates, and many other congenital abnormalities. If your family has been affected by Zofran, you may be entitled to significant compensation. Please contact an experienced pharmaceutical attorney to explore your legal rights.

Timeline of Events

The background of the Zofran lawsuit extends to the 1980s. In 1983, the drug Bendectin was withdrawn from the U.S. market, leaving pregnant women without an FDA-approved option to prevent nausea and vomiting. These symptoms of morning sickness appear in about 80 percent of pregnancies, and can be severe. Extreme cases, called hyperemesis gravidarum, are a common cause of hospitalization in the early stages of pregnancy.

In the early 1980s, GSK began testing Zofran on animals. The company declared the drug to be safe, although data from the studies show that the active ingredients could cross the placenta to the fetus, and cases of toxicity, malformations, and intrauterine deaths were noted.

Since that time, there has been increasing evidence of complications in humans related to this drug:

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• 1991 - Zofran was released to the U.S. market after receiving clearance by the FDA for treatment in cancer patients.
• 1992 - First adverse event reports were received by GSK concerning birth defects associated with Zofran.
• 2006 - A Hong Kong clinical study was published, demonstrating that Zofran could cross the placenta and potentially disrupt fetal development.
• December 2006 - GSK’s exclusive Zofran patent expired. Other manufacturers, such as Sandoz International (a Novartis subsidiary) soon began producing the generic ondansetron.
• September 2011 - The FDA issued a warning regarding Zofran’s possible link to abnormal heart rhythm problems in cancer patients, and asked GSK to conduct new safety studies.
• November 2011 - A study published by researchers from Harvard, Boston University, and the Centers for Disease Control (CDC) found that pregnant women using Zofran were more likely to have a baby with a cleft palate.
• July 2012 - GSK settled civil and criminal charges filed by the U.S. government, and agreed to pay over $3 billion for allegations that included marketing Zofran to pregnant women. The lawsuit included fraud charges and claimed that GSK bribed doctors to influence them to prescribe Zofran and other drugs.
• December 2012 - The FDA issued a recall of high-dose, intravenous (IV) Zofran used to prevent nausea and vomiting in cancer patients, after severe, life-threatening cardiac complications were reported.
• August 2013 - A Danish study reported detecting a twofold increase in the risk of congenital cardiac malformations with ondansetron and a 30 percent overall increased risk of major congenital malformations.
• June 2014 - The Canadian newspaper, The Toronto Star, published an investigative report concerned with Zofran side-effects that had been filed with the FDA between 2010 and 2013. The report included information about 20 Canadian women who were treated with the drug and suffered adverse outcomes, including babies with congenital kidney and heart defects, fetal growth restriction, and two infant deaths.
• October 2014 - A study was published by Swedish researchers who concluded that Zofran use in early pregnancy resulted in a higher risk of a baby being born with a heart defect, especially cardiac septum defects.
• December 2014 - A clinical study was reported confirming that ondansetron passes through the placenta to the fetus, and that the drug remains in the fetus for a longer period of time than the mother.
• February 2015 - The first plaintiff lawsuits filed against GSK included a Massachusetts mother who took Zofran for nausea and vomiting and delivered a daughter with several birth defects. The child has had multiple surgeries to correct structural abnormalities such as heart defects and facial dysmorphia.
• October 2015 - Twelve Zofran lawsuits were consolidated into multidistrict litigation (MDL) under Judge F. Dennis Saylor in the District of Massachusetts.
• December 2015 - A Canadian class action lawsuit was filed by 12 women claiming birth defects resulting from ondansetron use.
• January 2016 - With 211 consolidated lawsuits pending, U.S. District Court Judge F. Dennis Saylor denied GSK’s motion to dismiss the suits.

About the Zofran Lawsuit

Zofran is effective in the prevention of prenatal nausea and vomiting, and women have delivered healthy babies after ingesting the drug. However, it has become increasingly clear that Zofran is also associated with an increased risk of birth defects. Clinical studies and hundreds of claims have connected Zofran with a variety of adverse events, including:

• Heart defects, such as Atrial Septal Defect, Ventricular Septal Defect, Supraventricular tachycardia, and Tetralogy of Fallot
• Cleft palate and Cleft lips
• Microcephaly
• Club Foot
• Kidney Defects
• Abdominal Defects
• Spina Bifida
• Fetal Growth Restriction
• Skull Deformities
• Stillbirths and spontaneous abortions

The current status of the Zofran lawsuit has more than 220 plaintiffs consolidated into MDL. MDL is considered to be an optimal way of litigating product liability cases, when there are numerous plaintiffs with similar claims against a single defendant. It allows for increased efficiency, but does not bind individual plaintiffs to a single group outcome. This is in contrast to class action lawsuits, where a small group obtains a verdict that applies to all participants.

Damages in these cases may include medical expenses, lost wages, pain and suffering, and expected future losses.

The Zofran lawsuits allege that GSK failed to adequately test Zofran for use during pregnancy, and that the company marketed a potentially unsafe drug to pregnant women and healthcare providers.

Legal Help for Families

Many pregnant women have used Zofran since the late 1990s. If you were prescribed this drug and suffered complications in your pregnancy, including birth defects, you may be entitled to compensation. Damages in these cases may include medical expenses, lost wages, pain and suffering, and expected future losses. Even if you gave birth years ago, your family may qualify for participation in the Zofran lawsuit. To arrange a complimentary case evaluation, please contact an experienced pharmaceutical lawyer.