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Zofran Lawsuits: From 2015 Controversy to 2024 Implications

by | Jan 5, 2024 | Mass tort, Product liability

Is Zofran birth injury resulting in a mass tort?

GlaxoSmithKline (a pharmaceutical company) defeated more than 400 Zofran lawsuits alleging Zofran causes birth defects. Which means it scored a big win!

Is this success evidence that Zofran does not cause birth defects? Let me help you to find a solution to the query through this article.

Here, you will come to know about Zofran, its history, uses, types, side effects, lawsuits, and also hints on how to claim for the birth defects caused by Zofran.

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Before getting into the topic, know about the medical record review, which will be a crucial document for the success of your Zofran lawsuit.

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What is Zofran?

Zofran is a drug that’s generally called Zofran ondansetron and is employed for the treatment of nausea and vomiting from chemotherapy or surgery.

History of Zofran

Zofran was enlightened by GlaxoSmithKline in the mid-1980’s in London. The studies clearly mentioned that Zofran has been an exceptionally good drug for nausea and vomiting and for recovering patients from surgery or chemotherapy since 1991, when the Food and Drug Administration approved it.

In late 2006, the first version generic for Zofran was approved by the Food and Drug Administration. Although Zofran was originally created in 1984 to treat nausea and vomiting in cancer patients after chemotherapy, today the drug is most commonly used by pregnant women.

Uses of Zofran

  • Zofran is used alone or with other medications to stop nausea and vomiting caused by antineoplastic treatment (chemotherapy) and therapy.
  • It will also help prevent and treat nausea and vomiting after surgery.

Zofran Dosage for Kids

Zofran pediatric dose depends upon the age and weight of the child, the dosage limits of Zofran change. Take the drug as per the instruction of the physician. Children at the age of 4–11 can take 4 mg every 8 hours for 1 to 2 days.

Adult Zofran Dose

For adults 12 years of age or older, they can take 8 mg every 12 hours for 1 to 2 days. The dosage of Zofran will be different depending on the patient. Therefore, it is better to follow the prescriptions of the physician.

Types of Zofran

  • 2 mg/L of Zofran Injection (approved 1991)
  • 32 mg of Zofran Premixed Injection (approved 1995; recalled 2012).
  • Tablets of Zofran, 4 mg and 8 mg (approved 1995)
  • 4 mg/5 mL oral solution of Zofran (approved 1997)
  • 4 mg and 8 mg oral disintegrating tablets of Zofran (approved 1999)

But why did people and lawyers file a lawsuit against Zofran?

Zofran really helps people endure their sufferings. But lawsuits were filed against GlaxoSmithKline in a mass number because it doesn’t warn people that Zofran causes birth defects in the unborn child if the mother takes it during pregnancy. Moreover, it may result in an infant’s death.

Zofran Side Effects

Some common side effects of Zofran include

  • Drowsiness
  • Headaches
  • Constipation

The drug also causes birth defects. If a patient has hypersensitivity to an antihistamine, they ought to discontinue use.

Zofran and Pregnancy

Women are supposed to face many changes during and after pregnancy. Some of those changes are welcome, such as healthy hair, nails, and skin.

Other changes are less than pleasant, with symptoms such as nausea and vomiting being common, especially in the first trimester. Some pregnant women who are looking for relief from these unwanted symptoms turn to medication.

While some drugs have been approved by the FDA for use during pregnancy, others have not.

The Food and Drug Administration never sanctioned Zofran for the treatment of pregnant women, but it has been prescribed for nausea within the 1st trimester of pregnancy, where it may result in birth defects.

Can women take Zofran during pregnancy?

A meta-analysis stated that intake of Zofran within the first trimester could cause a small increase in the risk of heart defects and orofacial malformations like congenital disorders in babies. Therefore, Zofran with pregnancy leads to a birth defect.

In 2012, Harvard researchers found that infants exposed to Zofran during pregnancy had a 2.37% increased risk of cleft palate, and an Australian study reported a 6-fold increased risk of kidney obstruction associated with birth defects due to Zofran.

Zofran for Morning Sickness

Morning sickness in pregnancy will affect most women within the first few months. It is harmful not only in the morning but also at any time. One of the medications they prescribe for nausea is Zofran, an off-label drug that will result in a congenital anomaly

As Zofran generics became available, it became cheap and doctors began to prescribe it more commonly.

Is Zofran causing birth defects?

Sadly, yes, Zofran causes birth defects in infants. Also, studies show that Zofran causes birth injury when the mother takes it during the first trimester.

Zofran Pregnancy Birth defects

If the mother of the infant consumes Zofran during her pregnancy, the probability of birth defects is high for the infant. The  birth defects that Zofran causes are as follows;


Zofran Birth Defects:

Some of the most common Zofran birth defects are

  • Heart defects, sort of a hole within the heart
  • Cleft lip and congenital anomaly
  • Renal agenesis: either one or both kidneys do not develop.
  • Other organ malformations

Is there a lawsuit against Zofran?

Of course, Yes, Zofran isn’t approved by the FDA for pregnant women because there’s no evidence to suggest that Zofran is safe for infants within the mother’s womb.

But GlaxoSmithKline has even promoted the use of Zofran in pregnant women, which has resulted in a huge number of Zofran birth defect lawsuits.

Why don’t drug companies give an honest warning?

Why don’t pharmaceutical companies put all the risks in their drug leaflets?

Why not just avoid trouble by revealing everything?

The reason is profit.

When you give patients and their doctors all the information about how a product can hurt or kill them, you will sell less of that product.

Doctors and patients often have a choice between medications. Doctors try to put their patients on the best drug possible to solve their problem—the drug with the lowest risk. If one drug takes a risk that another doesn’t, it becomes much easier to call the doctor, and this is reflected in the market share.

Zofran and Pregnancy 2023

While the truth about Zofran was revealed by FDA that it was not approved for pregnant women, a lot of lawsuits were filed against the GSK.

Birth Defect Lawsuit

Marketing Zofran for pregnant women and coming under fire by the Justice Department was not the first time for GlaxoSmithKline.

Knowing Zofran and the birth defect it results in, the FDA also sent a warning letter to GSK in March 1999, for distributing promotional materials including Zofran that lacks fair balance.

As Glaxo failed to present any information about the risk of Zofran, DDMAC (Division of Drug Marketing, Advertising and Communications) violated the Federal Food, Drug, and Cosmetic Act against GSK.

DDMAC also forced GSK to cease using Zofran promotional material that lacks risk information.

Zofran Lawsuits

On Lincoln’s Birthday, 2015, the primary lawsuit was filed against Zofran birth defect in the U.S. District court by Cheri Flynn, a Minnesota mother, after her two daughters were born with serious heart abnormalities.

Flynn was prescribed Zofran cure morning sickness, leading to a daughter born in 2004 being developmentally delayed and a second daughter born in 2006 also plagued by a congenital heart defect.

Following her, a variety of lawsuits were quickly filed against GlaxoSmithKline.

Zofran Birth Defect Lawsuits

Judge Saylor ruled to permit over 200 Zofran lawsuits to proceed in January 2016. After that, the number of Zofran lawsuits moved to 238 by March and jumped to 259 after two months. In September 2018, it was noted that quite 600 actions had been filed. More than 100 women claimed that GSK’s off-label marketing led them to require Zofran and was the rationale for their children’s birth defects. Nearly 425 people walked to court after their children suffered birth defects like cleft palates, skull deformities, and heart defects after their mothers were prescribed Zofran for sickness.

GSK clearly did not warn the general public despite being alert to three animal studies indicating the hazards of Zofran. The plaintiffs also filed a case against Glaxo, putting forward the 32 reports of birth injuries 15 years ago in children whose mothers took Zofran.

Zofran Lawsuits—Zofran Birth Defect

Giving priority to personal injury lawsuits in 2015, the U.S. Department of Justice filed a lawsuit against GSK for marketing Zofran to pregnant women. GSK paid a fine of $3 billion to resolve claims from the center for failing to report safety data and marketing several drugs off-label that weren’t approved by the FDA, including Zofran in 2012. Glaxo is currently dealing with an increase in Zofran litigation for failing to alert physicians and patients to the supposedly high risk of significant side effects, such as cleft palate and cardiac problems.

Zofran Lawsuits Update 2022

On May 4, 2020, the first Zofran birth defect trial was scheduled. This lawsuit is related to one that was filed by the parents of a little girl, who claimed that the mother’s use of Zofran caused their daughter’s heart problems. That trial date was erased by COVID. So, when the trials resume, we’ll find out. The judge intended to delay the trial until the end of 2020, in June. However, it’s obvious that a Zofran birth injury experiment took place in 2020. We already know that one is unlikely to exist in 2022.

Zofran lawsuits update 2023

Invoking the FDA’s recent denial of a request to include a warning, Judge F. Dennis Saylor determined that the FDA would not have permitted a pregnancy warning to be added to the label of Zofran. In the MDL class action litigation, this decision dismissed 425 Zofran birth defect lawsuits. In January 2023, the 1st Circuit Court of Appeals agreed with Judge Saylor, effectively ending every Zofran lawsuit in the United States.

How long does it take to sue for pharmaceutical injury or wrongful death?

There is no time limit on the duration of a drug trial. But the truth is that time is usually measured in years, not months, in most MDL class action lawsuits.

File Birth Defect Lawsuit

If you or your loved one took Zofran during pregnancy and your child was born with an anomaly, file a Zofran birth defects lawsuit you’ve got two choices—either join a  mass tort lawsuit or file a separate personal injury claim against the manufacturer.

Anyone might experience emotional upheaval upon learning that their newborn child has a birth abnormality, especially if the issue may have been brought on by a commonly given medication.  Both suits have their advantages. A mass tort lawsuit is meant to represent the greatest number of victims in a fight against an outsized entity. A private injury lawsuit is what it sounds like—your sole claim alone against the manufacturer. In the Zofran birth defect, both are applicable.

Fighting for the law against the top pharma company is not at all an easy task, but professional and experienced lawyers are always ready to stand with you and fight for your rights through Zofran lawsuit-birth defect claims. Do not overlook the importance of medical records in a Zofran birth defect lawsuit.

Medical records can act as strong evidence when they are error-free, without any confusing and contradictory statements. LezDo TechMed assists attorneys like Zofran birth defect lawyers in reviewing medical records of the plaintiffs.

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We are experts in extracting the relevant data from medical records and presenting them as evidence in the lawsuit. It is hard for any parent to be the reason for their child’s suffering. Without their acknowledgment, women took drugs like Zofran and their infants suffered or were put to death.

If the case is filed and proven, the government will take action against the manufacturer and make them compensate for it. The compensation will not equalize your loss, but it will help you overcome your financial battle. Any nation will benefit from producing a healthy generation, which shouldn’t be hampered by obstacles like Zofran.

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