Update: GSK Wants Generic Zofran Lawsuits Dismissed

November 9, 2016 – GSK argued in a motion filed last month that Judge F. Dennis Saylor IV should dismiss at least 27 lawsuits filed on behalf of women who allege they had children with birth defects after they were prescribed a generic version of ondansetron for morning sickness during pregnancy. The company claims the suits were filed under state laws that “do not permit a defendant to be held liable for a product it did not manufacture, sell, or distribute.”


Zofran (ondansetron) is an anti-nausea drug made by GSK that prevents vomiting by speeding up gastric emptying. It was approved by the FDA in January 1991 for the treatment of chemotherapy patients.

Zofran and Pregnancy

Zofran is not approved for use during pregnancy. It is a “Pregnancy Category B” drug, which means there are no adequate or well-controlled studies in pregnant women. The fetal safety data on Zofran is based on studies in pregnant rats and rabbits in the 1980s, and fewer than 200 births in humans.

Zofran Used “Off-Label” for Morning Sickness

In the last two decades, Zofran has become a popular “off-label” (unapproved) treatment for pregnant women suffering from morning sickness. Very severe morning sickness (Hyperemesis Gravidarum) can be deadly for both mother and child.
Zofran became popular because there was no FDA-approved drug for morning sickness after 1983. That changed in 2013, when the FDA re-approved Diclegis (formerly marketed as Bendectin in the 1950s). Diclegis is a “Pregnancy Category A” drug that combines Vitamin B6 plus an antihistamine. Its fetal safety in humans is well-established.

Zofran Drug-Maker Pays $3 Billion for “Off-Label” Marketing

In July 2012, GlaxoSmithKline agreed to plead guilty and pay a $3 billion settlement to the Justice Department. The settlement resolved criminal and civil allegations of illegal “off-label” marketing of several drugs, including Zofran to pregnant women with morning sickness.

Studies Link Zofran and Birth Defects

In February 2013, the New England Journal of Medicine published a study that found no link between Zofran and birth defects. Conclusions were based on data from a Danish registry of pregnancies between 2004 and 2011. Interestingly, half of the babies were exposed to Zofran after the first trimester, when they were no longer at risk of major birth defects.
Meanwhile, another researcher presented data from the same Danish registry, but covering more years (1997–2010) and more pregnant women (897,018 versus 608,835).
The researcher, Dr. Jon A. Anderson, concluded that Zofran doubled the risk of heart defects, leading to a 30% overall increased risk of major birth defects. Out of nearly 1,250 pregnant women who used Zofran, 4.7% had a baby with a birth defect, compared to 3.5% of non-users.
Dr. Anderson’s conclusions are backed up by another study published in 2013 by researchers in Australia, who concluded that Zofran increased the risk of birth defects by 20%.
The Australian researchers also found a 6-fold increased risk of kidney malformations, described as “obstructive defects of renal pelvis and ureter,” but the estimate was based on small numbers and was imprecise. Interestingly, prescriptions for Zofran in pregnant Australian women increased 5-fold between 2002-2005 for unknown reasons.

Zofran and Cleft Palate

In January 2012, a study published in Birth Defects Research linked the use of Zofran with a 2.4-fold increased risk of cleft palate. Conclusions were based on data from 9,000 pregnancies and the study was conducted by researchers affiliated with the Centers for Disease Control (CDC).

What’s the problem?

Schmidt & Clark, LLP is nationally recognized as a class action law firm, but our attorneys are not filing a Zofran class action. Instead, we are filing individual lawsuits because we believe personal legal representation is the best way we can help people who have been harmed by this drug.

Birth Defects

We are evaluating cases linking Zofran and the following birth defects:

  • Heart defects
  • Heart murmur (abnormal sound in the heart)
  • Atrial septal defect (“hole in the heart”)
  • Cleft lip
  • Cleft palate
  • Fetal growth restriction (poor growth in the womb)
  • Jaundice
  • Kidney defects
  • Musculoskeletal malformations
  • Pregnancy complications
  • Fetal death

Zofran Risks for Pregnant Women

The FDA has issued several warnings about Zofran side effects that could be deadly for a pregnant woman, including:

Zofran Lawsuit Filed in Massachusetts

October 7, 2016 – A woman from Oneida, New York whose son was allegedly born with a cleft lip and cleft palate after she took Zofran during pregnancy has filed a lawsuit against GSK. Plaintiff claims she was prescribed a generic version of Zofran for morning sickness during her first and second trimesters, and that her son was subsequently born with “a cleft hard palate [and] unilateral right cleft lip.”

Thousands of Former Users Could Still Pursue Legal Action

February 11, 2016 – Of the nearly 4 million births in the U.S. each year, 10-15% of mothers suffer symptoms of extreme morning sickness (hyperemesis gravidarum).This means that on average, 400,000 – 600,000 babies are exposed to anti-nausea medications in the womb. Although never approved for this purpose, the most widely-prescribed drug for morning sickness in America is Zofran.

GSK Pushes to Split Generic & Name Brand Zofran Lawsuits

February 25, 2016 – In a court filing (PDF) submitted this week, GlaxoSmithKline has requested a “product identification” mandate for the Zofran MDL that would require plaintiffs to identify whether they took the brand name version of the drug or a generic. Courts have traditionally ruled that brand name drug makers cannot be held liable for injuries caused by generics. However, generic manufacturers are unable to update their products’ warning labels with new risks until the brand name manufacturer does so first. This is especially problematic considering the fact that at least 30 different companies make their own version of ondansetron, the active ingredient contained in Zofran.

Judge Denies GSK’s Motion to Dismiss Zofran Lawsuits

February 2, 2016 – The federal judge overseeing the Zofran multidistrict litigation (MDL) in Boston has denied a motion by GlaxoSmithKline (GSK) to remove the cases from court. GSK’s motion to dismiss was based on federal preemption law, with the drugmaker arguing that the FDA had previously denied a stronger warning label for Zofran. District Judge F. Dennis Saylor IV disagreed, stating that “The plaintiffs [should be given] some opportunity to develop the facts, whatever those facts may be.”

Zofran Lawsuits Consolidated in Massachusetts

October 13, 2015 – All federally-filed lawsuits alleging Zofran caused birth defects have been consolidated into a multidistrict litigation (MDL 2657) in the District of Massachusetts before Judge Dennis F. Savor, IV. The MDL is intended to facilitate judicial efficiency and preserve the resources of the Court, parties and witnesses. Click here to learn more.

Lawsuits Mount as Plaintiffs Disagree with GSK’s Proposal for MDL

August 13, 2015 – At least 19 plaintiffs have responded to GSK’s request to centralize all federal Zofran Birth Defect Lawsuits into a multidistrict litigation (MDL). All responses have come in support for the proposed consolidation; however, the plaintiffs disagree on the drugmaker’s choice of venue for the proceedings.
GSK has requested the U.S. District Court, Eastern District of Pennsylvania, which is the closest venue to the company’s U.S. headquarters in Philadelphia. However, plaintiffs argue that other jurisdictions would be more suitable.
It is still unclear as to when the U.S. Judicial Panel on Multidistrict Litigation (JPML) will decide on the venue. However, the Panel could hear oral arguments on the matter at its next hearing session on October 1 in New York City. The MDL is: In Re Zofran Products Liability Litigation – MDL 2657.

Zofran Lawsuits Alleging Birth Defects

  • Case 1:15-CV-10429 – Filed on February 16 in U.S. District Court for the District of Massachusetts, Eastern Division by a Boston woman who allegedly had a child with the following birth defects after she took Zofran during her first trimester of pregnancy: atrial septal defect; right ventricular hypertension; aortic arch hypoplasia; facial dysmorphia; low set ears; hearing loss; sensitivity to light; inguinal hernia, and webbed toes.

According to the complaint, the child has undergone at least 13 different surgeries and continues to suffer from developmental delays and other adverse health problems. The lawsuit accuses GSK of failing to warn about the risks associated with using Zofran in pregnancy.

  • Case 2:15-CV-00709 – Filed by a Minnesota woman who allegedly delivered 2 children with congenital heart defects. Specifically, the plaintiff claims her first child, “B.F.”, was born premature in 2004 with a cardiac septal defect and severe developmental delays. In 2006, plaintiff’s second child, “T.F.”, was also born premature and with a cardiac defect, respiratory problems and continues to suffer from abnormally slow development.
  • Case CGC-15-544524 – On March 5, 2015, a San Francisco couple filed a product liability lawsuit against GSK alleging that Zofran caused their baby to be born with bicuspid aortic stenosis, a severe congenital heart defect that occurs in early fetal development, around the same time an expecting mother is likely to experience the symptoms of morning sickness.

According to the lawsuit, the mother was prescribed Zofran early in her first trimester “to alleviate the symptoms of morning sickness.” However, the complaint notes that Zofran is not and has never been approved by the FDA to treat morning sickness.

  • Case R615761042 – Filed on March 6 in California Superior Court by an Oakland woman who allegedly took Zofran while pregnant and gave birth to a baby with supraventricular tachycardia, a condition that occurs when the heart beats extremely fast due to an electrical malfunction. The complaint alleges the defect was the direct and proximate result of the baby’s exposure to Zofran in utero.
  • Case 1:15-CV-00026 – Complaint entered April 3 by a Montana couple who alleges Zofran caused their daughter to be born with a cleft palate. The girl has since had to undergo 10 surgeries “to try and correct her cleft lip and palate,” and is expected to need additional treatment in the future as she continues to grow. Plaintiff claims that had she been aware Zofran could increase risk of birth defects, she never would have taken it.

Zofran Recall

On Dec. 4, 2012, the FDA issued a Drug Safety Communication (PDF) which stated that it was recalling the 32mg dose of Zofran. According to the warning, the 32 mg IV solution increased a patient’s risk of developing QT interval prolongation, or irregular heart rhythm. This abnormal heart rhythm could cause Torsades de Pointes, a life-threatening heart rhythm.

About Class Actions

When most people consider filing a lawsuit against a major pharmaceutical company, the first thing that comes to mind is a class action. You may be familiar with the class action process if you have decided to seek reimbursement for a defective product, for example.

Why Our Law Firm is Filing Individual Lawsuits as Opposed to a Zofran Class Action Lawsuit

Class actions are a good way to help thousands of people who have the same legal claim, but they are not usually designed to maximize financial compensation for a small number of people with very serious injuries.
You have probably heard about unscrupulous class action attorneys accepting “low-ball settlements,” taking huge cuts of the payout, and dividing the rest among everyone in the class action.
Instead of a class action, our attorneys only file individual lawsuits. We only accept cases involving very serious injuries. We invest our time and money into your legal representation and typically work on contingency-fee, which means we don’t get paid unless you win.

How Can a Lawsuit Help?

Birth defects can be devastating in a number of ways. Young children often must endure painful surgeries and a lifetime of disability and medical care. Parents and families can be devastated by the financial costs of treatment.
Fortunately, you have a right to file a lawsuit and seek compensation. There is no excuse for pharmaceutical companies who fail to warn about the risk of birth defect side effects from their defective drugs, putting corporate profits above your child’s health.

Do I have a Zofran Class Action Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.
Free Confidential Case Evaluation: Again, if you or a loved one had a baby with a birth defect, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 588-0600.