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Zofran Lawsuits

Zofran Lawsuits and Birth Defects

There is a connection between using Zofran for nausea and morning sickness within the first trimester of pregnancy and several fetal injuries. These fetal injuries include: cleft palate, cleft lip, club foot, craniosynostosis (skull deformities), and congenital heart disease. We are convinced that there is substantial evidence that Zofran can cause these defects, which is why you may be eligible to file a claim with Zofran lawsuits.

Zofran lawsuits are being filed because the Food and Drug Administration (FDA) only approved this drug for treatment of nausea in patients recovering from surgery or chemotherapy. It was not approved as a drug for morning sickness during pregnancy. That is one of the reasons why GlaxoSmithKline (GSK), the manufacturer of the drug, had to pay over $2 billion as settlement in a Zofran lawsuit. GSK was found guilty of illegally promoting this drug for prescription to pregnant women.

However, this initial settlement by GSK did not include settlement for injuries because of the use of Zofran. You and your infant may be eligible to file a Zofran lawsuit and ask for compensation for undue suffering and pain, loss of income, medical bills, and other types of damages. Here is additional information about Zofran that will help you to know if you qualify for a settlement from GSK.


Unauthorized Zofran Use

The U.S. FDA only approved Zofran to give patients relief from nausea after surgery. It helped patients who vomited as a result of cancer treatment or after taking post operative medication. It was prescribed to help patients with pain and other complications. But GSK soon found another way to get Zofran prescribed – to expectant mothers who were experiencing morning sickness. This was done, however, without FDA’s approval. Zofran has gained a large market share in form of an “off label” prescription for pregnant women. Unfortunately, there’s no law stopping doctors from prescribing such drugs “off-label”.


Birth Defects and Related Studies that Support Zofran Lawsuits

Our investigations have revealed that several studies provide evidence to support the fact that Zofran poses a threat to the health of the growing baby, especially in the first 3 months of growth. In 2013, some researchers in Denmark provided the results of a study that was conducted from 1997 to 2010 on almost 900,000 expectant mothers. This study showed a two-fold increased risk of infants developing cardiac malformations after the mothers used Zofran. In order to rule out the possibility of other indications, the researchers examined metoclopramide which is also used to treat morning sickness, and they found no increased risk of developing birth defects.

In the later part of 2013, a published research paper in Australia also showed that there was a 20% rise in the risk of significant birth defects among infants exposed to Zofran in the first three months of pregnancy. In 2014, another Danish study, conducted with the support of their National Board for Health and Welfare, showed that taking Zofran during pregnancy amplified the risk of cardiovascular malformations in children – especially malformations in the cardiac septum.

In 2014, the Toronto Star, a popular Canadian newspaper, performed an investigation on Zofran and birth defects. The study revealed that 20 Canadian mothers who took this drug during pregnancy had fetal side effects such as kidney and heart defects, low birth weight, and infant death. The heart defects observed were atrial septal and heart murmur defects.


What You Should Know About Cleft Lip and Cleft Palate

A cleft lip is a separation or split of both sides of the baby’s upper lip. This is usually obvious at birth. To correct this birth defect, doctors usually perform a surgery to restore the function and appearance of the upper lip. However, this restorative surgery may not be performed until the baby has attained a weight of 10 pounds and is about 10 weeks old, with a hemoglobin count of about 10 grams. The hemoglobin is a kind of protein present in red blood cells which shows if there’s a high risk of excess bleeding. You may contact us, about the possibility of filing a Zofran lawsuit through our firm, if your baby has a cleft lip and you took Zofran during pregnancy.

Cleft palate is a split in the roof of the infant’s mouth which may extend from the hard upper plate in front to the soft palate at the throat. Sometimes, this opening can affect the nose and the gums and also lead to a cleft lip. An infant with this condition can experience serious difficulties with hearing, speech and feeding. Efforts to correct a cleft palate usually begin when the child is about six months old. You may also get in touch with us for an evaluation, before you file a Zofran lawsuit, if your child has a cleft palate and you took Zofran while you were pregnant.


Reasons Why Previous Zofran Users are Filing Zofran Lawsuits

Court documents reveal that GSK was aware as early as 1992 that Zofran posed a reasonable risk of harm to developing babies due its ability to pass to the human placenta. However, with this knowledge, GSK continued to sell the drug to expectant mothers.

Zofran lawsuits make a couple of claims against GSK including:

* That GSK was duty bound to make sure Zofran was perfectly safe before marketing it publicly but failed to ascertain its risks and side effects before selling it

* That GSK refused to warn users about the harmful side effects of Zofran

* That GSK advertised Zofran as medication for the safe treatment of hyperemeis gravidarum and morning sickness although it was not approved by FDA for such use.

Zofran lawsuits also establish the fact:

* That GSK presented false evidence about animal studies that showed Zofran was safe, when the results actually revealed signs of toxicity and abnormal bone growth

* That GSK did not properly analyze and evaluate all safety information and data on the drug for use in expectant mothers

* That GSK fraudulently claimed that Zofran was safe for consumption by pregnant women.


Get Legal Help Today

If you need to file a Zofran lawsuit, we can be of help to you. There are many lawsuits in the court system which accuse GSK of selling Zofran to pregnant women without approval and paying physicians kickbacks to prescribe it to them. This drug provided millions of dollars in sales for GlaxoSmithKline because about 1 million women took this drug or its generic equivalent every year. You could be eligible for compensation through a properly filed Zofran lawsuit. Call now for an evaluation, to know if you have legal options against GSK, the producers of Zofran.