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As a parent of a child with special needs
and board member of The Cleft Lip
and Palate Foundation Of Smiles,
I understand what you are going through.

- Michael Monheit, Esq.

Call Now: (877) 620-8411

We support the Cleft Lip and Palate Foundation of Smiles

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pursue justice for your family.

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Call Now: (877) 620-8411

Welcome To The Zofran National Legal Resource Center

Welcome to the Zofran / Ondansetron child birth defect legal center. is sponsored by the experienced Mass Tort law firm, Monheit Law. We are currently accepting cases where your child sustained a child birth defect, such as a heart condition, cleft lip and/or cleft palate after you took Zofran for morning sickness during your pregnancy.

We Are Here To Help You Understand Your Legal Rights

You may have seen a TV or internet advertisement about the Zofran litigation, and now you are looking for answers. We know this is a confusing time. We understand the emotions you will be going through. We are here for you and we will answer any questions you have.

Call 877-620-8411 for a free consultation with our experienced Zofran lawsuit attorneys.

Frequently Asked Questions You Want Answers To

If you prefer to do your own research first, please browse around this website for a robust understanding of the Zofran child birth defect litigation. Below are some questions that may help you get started:

We have many other questions in our frequently asked questions section, which you can access here.

Summary Of Epidemiology Studies Linking Ondansetron and Child Birth Defects

Increased Risk Of Cleft Palate200%
Increased Risk Of Septal Defect22%
Increased Risk Of Cardiac Defect62%
Increased Risk Of Fetal Malformations30%

To read detailed summaries of all epidemiology studies, click here.

Zofran / Ondansetron Lawsuit Brief Summary

You may be asking why this litigation is only starting now? This is a good question, and below you will find a brief summary on the most relevant facts that have brought about this litigation.

13 Brief Facts About GlaxoSmithKline’s Zofran And This Litigation

  1. GlaxoSmithKline (GSK) manufactured Zofran (active ingredient: Ondensatron Hydrochloride) in the mid 1980s
  2. In the 1980s GSK performed Zofran testing on rabbits and rodents. These tests showed evidence of toxicity, malformations, and intrauterine deaths in the animals
  3. In 1991 the Food & Drug Administration (FDA) approved the drug for sale in the United States to patients who were suffering from extreme nausea as a result of chemotherapy, radiation therapy, and for certain post operative procedures
  4. The FDA never approved Zofran as a drug for morning sickness that was safe for pregnant women
  5. GSK did not take the drug through an approval process for the drug to be given to women for morning sickness. GSK commenced marketing Zofran from 1991 onward as a “safe” solution to vomiting, nausea, and morning sickness during pregnancy
  6. In 1990, GSK was notified of 2 birth defects linked to mothers ingesting Zofran during the first trimester of pregnancy
  7. By the year 2000, GSK was aware of 32 reported instances of a birth defect attributed to ingestion of ondansetron by the birth mother for morning sickness. As of today there are over 200 reported defect cases
  8. Several epidemiological studies were performed from the 1990’s onward which may support a link between Zofran and child birth defects, in particular, cleft palate, cleft lip, and congenital heart defects
  9. GSK has never performed any clinical trials on Zofran in pregnant women to gain FDA approval. GSK has never modified the drug’s label with warnings of child birth defects
  10. In 2012, GSK settled claims brought by the US Government and paid a record high $3 billion fine. This settled the allegations for GSK’s “off-label” promotion of drugs and kick-backs / colluding with medical professionals to prescribe their products. This settlement included the allegations for the marketing of Zofran to pregnant women who were suffering from morning sickness, and included allegations of paying kick-backs to physicians to prescribe ondansetron for morning sickness to make GSK billions of dollars
  11. GSK continues to deny all allegations relating to Zofran causing birth defects. GSK has offered no warnings that the drug is unsafe for pregnant women and has not asked the FDA to do so either
  12. Personal injury lawsuits and class actions are being filed against GSK as of February 2015
  13. A Multidistrict Litigation for Zofran lawsuits was formed in Boston, MA to administer pretrial discovery and bellwether trials in October 2015

Breaking Zofran Lawsuit Updates

December 15, 2015 – Nearly 200 Lawsuits Now Consolidated In Boston

Lawsuits claiming that GlaxoSmithKline’s nausea drug Zofran causes birth defects have flooded the US District Court for Massachusetts. Almost 200 lawsuits have been transferred so far, in preparation for commencement of pre-trial proceedings in the Zofran Multi-District Litigation (MDL). The Honorable F. Dennis Saylor IV has been appointed to preside over the litigation.

Common when numerous lawsuits share a set of allegations, MDL allows Plaintiffs to come together in one Federal Court for the crucial phase of discovery, in which evidence is gathered. After pre-trial measures are complete, it’s likely that the court will select several lawsuits to proceed to trial first. The outcome of these “bellwether trials” may inform settlement decisions in the future.

January 4, 2016 – Inexplicable Increase In Birth Defects Puzzles Washington State

Medical researchers in Washington still can’t explain why three of the state’s counties have seen a shocking rise in the rate of one extremely severe birth defect. In Yakima, Benton and Franklin counties, hospitals record five times the number of anencephaly cases born in medical facilities nation-wide.

Since 2010, 41 women have given birth to children with the rare, fatal neural tube defect, reports the Seattle Times. But the vast majority of these women haven’t heard anything from Washington’s health officials. In fact, researchers concerned about the rash of birth defects way back in 2014 say they were ignored by the US Centers for Disease Control & Prevention.

Child Birth Defects Caused By Taking Zofran For Morning Sickness

Note, this is not an exhaustive list, but a list of common defects that we have seen in speaking with those affected:

  • Cleft palate and/or cleft lip – facial dysmorphia
  • Congenital heart defect – atrial septal defect, ventricular hypertension, aortic arch hypoplasia
  • Low set ears
  • Webbed toes
  • Hearing loss
  • Kidney malformations
  • Sensitivity to light
  • Ingueno hernia

What Are Your Next Steps?

Again, we understand the anger you are feeling at this moment. You may believe that your family has been hurt by the corporate drug giant GSK. You are not to blame for what your child went through. At Monheit Law, our compassionate attorneys are here to help you.

If you gave birth to a child who suffered a child birth defect and you took Zofran during your pregnancy, you may be entitled to fair and just compensation for the pain and suffering you, your family, and child experienced.

Call us today on (877) 620-8411. It is free. We are available 24/7.

You won’t pay anything until we recover compensation on your behalf.

What Our Clients Say About Us

Michael Monheit of
Reviewed by Rachel Mancuso, on .
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