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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.



Zofran Birth Defects

Zofran is a drug that has been taken by pregnant women to prevent nausea. It does this by blocking the production of a natural chemical called serotonin which is responsible for the feeling of nausea and vomiting. Although it is effective in reducing the feeling of morning sickness, it has many negative effects. This morning sickness drug increases the risk of birth defects including heart defects, cleft palate, cleft lip and many others which can be devastating. If your baby has one of many Zofran birth defects because you used Zofran while pregnant, you may consider filing a Zofran lawuit.

Obviously, there is no amount of money that can truly compensate the suffering that you and your child will go through because of Zofran. The compensation, however, will help you give the best care to your child.

Zofran was originally created for people who are suffering from cancer. It is prescribed to cancer patients for the treatment of nausea and vomiting they experience after going through chemotherapy. It is also used to treat nausea and vomiting that is experienced after going through a surgery.

The company, however, later discovered that pregnant women formed a huge market for their drug. Without considering the birth defects that their drug could cause, they immediately cross marketed Zofran, claiming that it is an ideal drug to treat nausea during pregnancy. It was later discovered that there are many birth defects related to Zofran use.  Zofran birth defects are serious and need immediate attention.

Why You Need the Services of a Zofran Birth Defects Lawyer

If you or a loved one took Zofran during pregnancy, you should contact a Zofran birth defects lawyer as soon as you can. This will ensure that you have someone working on your case as soon as possible. Here are the reasons why you should seek the services of an attorney if you give birth to a child with one of the Zofran birth defects;

  1. A lawyer will help you prove that your child suffered from a birth defect because of Zofran

There are many things that cause birth defects. It can be a tough job to prove beyond reasonable doubt that the birth defects that your baby is suffering from are a result of the Zofran that was taken during pregnancy. Remember, Zofran manufacturers will have the best attorneys to defend them to ensure that you do not receive any compensation. That is why you need someone who understands the law to ensure that they do not win against you.

  1. An attorney knows the best way to do things to ensure that you are compensated

There are plenty of things that need to be done for you to get compensated. If you are not a lawyer, you probably don’t know what to do to get justice. A Zofran birth defects lawyer will guide you through the process and do what needs to be done at every step to ensure that you have a strong case. This is something that you can do if you decide to seek justice by yourself. A lawyer, however, will know what evidence to look for and the things to say in court that will help you get the best compensation.

  1. A Zofran lawyer has dealt with many similar cases before

Experience is very important in the field of law. A lawyer who has dealt with many Zofran cases before has all the experience that is required to get the best possible outcome. Not all lawyers can adequately represent you in a case that is related to Zofran. To get the best representation in court, you need a lawyer who specializes in Zofran cases. Zofran cases can be very complicated. You need the services of a lawyer who is well versed with this type of case. You are more likely to get justice when you deal with a lawyer who has won many Zofran cases before.

  1. A lawyer will speak on your behalf at this difficult time

If you give birth to a child with birth defects caused by a drug that you took while pregnant, you will be in a difficult emotional state. In this emotional state, it is very difficult for you to make clear headed decisions. That is why you need someone who thinks clearly to help you get the compensation you need so that you can move on with your life swiftly. You can sit back and focus on  day to day life while your lawyer is working to get justice for the suffering that you and your child are going through.

  1. You will get the help you need to get the compensation that suits you best

Your claim is unique. All Zofran claims are unique and should be treated differently. The compensation that someone else got is not what you deserve. A good attorney will analyze your individual situation so that you get the compensation that suits you best. Your lawyer will file a suit that is based on your circumstances so that you are awarded based on your unique situation.

Remember, the likelihood of getting compensated depends on your case and the lawyer representing you. You may have a good case but if you have an inexperienced lawyer, you may not get any compensation.

That is why you need to be very careful when looking for legal representation for a Zofran birth defects case.



Zofran Heart Defects

Zofran is a serotonin 5-HT3 receptor antagonist prescription medicine that is primarily used to treat vomiting and nausea induced by undergoing cancer chemotherapy or radiation therapy.

It has also been proven to be effective in combating post-operative induced nausea and vomiting. Over the years physicians have also been in the habit of prescribing this drug to pregnant women who experience morning sickness and even hyperremisis gravidarum.


Zofran carries serious risks for unborn children

However, this off label usage of Zofran, which has been given the generic name of Ondansetron, has widely been reported to carry serious side effects not only to the mother, but also the unborn baby. In the latter scenario, this prescription medicine has been known to cause Zofran heart defects, mouth deformities, musculoskeletal anomalies and jaundice.


The FDA did not approve of Zofran usage by pregnant women

Indeed, according to a warning issued by the food and drug administration (FDA), Ondansetron usage by pregnant women can lead to potential serious birth defects. Despite this, many physicians continue to prescribe and administer this medicine to expectant mothers, with quite a majority of such cases being reported in Canada.


Zofran administration is especially dangerous during the first trimester of pregnancy

As all mothers would readily know from experience, the signs and symptoms of morning sickness usually manifest themselves during the first trimester of pregnancy.

This is also the time when critical development processes like cardiovascular development of unborn children take place. Many doctors persisted in prescribing Ondansetron during this crucial juncture of pregnancy without caring about the repercussions of their actions.


The FDA did not stop physicians from prescribing and administering Zofran

The shocking thing about all this is the FDA , other than issuing a warning, has not taken any effectual measure to prohibit the use of Zofran among pregnant women. On the other hand, physicians are now legally required to explain to expectant ladies the potential risks associated with using this drug, prior to administering it.

This is aimed as a precautionary measure that arises from the fact that Zofran is primarily designed for cancer patients and those who have gone through surgery. Despite this, quite a large number of doctors continue to prescribe this medicine as a viable off label treatment for morning sickness. Not paying heed to the serious risks their actions expose these women to.

Many studies have been carried out on Zofran and its probability of causing birth defects

Over the years many women have complained about the dire repercussions of using this drug while pregnant. This has triggered much research to be conducted on this topic to fully ascertain the extent of damage Zofran can cause to unborn children. Perhaps the most illuminating of these is the 2011 study that was funded by the Center for Disease Control (CDC).

This research revealed that Ondansetron does in fact double the risks of birth defects.


The United States Department of Justice has sued Zofran’s maker on irregularities in the marketing of its drugs

Coincidentally the United States Department of Justice filed a lawsuit in 2012 against the manufacturer of this prescription drug, GlaxoSmithkline. This arose from this firm illegally promoting the off label usage of its drugs including Zofran.

This case was eventually resolved with an out of court settlement of $3 billion.. What makes things even worse is the fact that GlaxoSmithkline readily admits the usage of this drug by pregnant women for treating nausea and vomiting has not been comprehensively evaluated.

Yet it still does continue to market the off label utilization by expectant women. This is a blatant disregard to the wellbeing of these ladies, and worse still, that of the babies they carry, and it is thus legally liable for prosecution for its reckless behavior.


You are legally entitled to make a compensation claim if your child was born with Zofran induced birth defects

Should you have recently given birth to a baby that was born with defects like Zofran heart defects due to your usage of this drug during pregnancy, you are entitled to make a compensation claim.

To fully address the anguish and pain that you and your family have been subjected to as a result of your baby’s birth disorder, a claim should be filed.  In addition, compensation from your claim will help offset the medical bills you may have incurred in the attempt to rectify these anomalies.


You should enlist the assistance of a law firm to ascertain the viability of your Zofran heart defects compensation claim

By consulting an experienced law firm that deals with this kind of lawsuit, you may be able to determine whether you are eligible to make a compensation claim. Also, it will determine just how much money you should request in your claim. These legal professionals have accrued a lot of experience in dealing with such lawsuits. This puts them in an excellent position to evaluate your own, taking into account the exact circumstances of Zofran administration during your pregnancy.

More to the point, if the physician involved did not warn you of the potential risks this drug could pose to your unborn child, and your child was born with Zofran birth defects, you are eligible for compensation.


Success is not guaranteed for all Zofran heart defects lawsuits

After determining this critical fact, these attorneys will plot out the right course of action in dealing with your case. Whether they should pursue an out of court settlement or fight it out in court, it is important, however, to realize beforehand that such lawsuits happen to be intricate and take into consideration many factors. There is, therefore, no definite guarantee that your compensation claim will be successful.


Despite this, it does pay to have an able legal representative for a Zofran heart defects claim

Doing this goes a long way in making sure that the odds of obtaining a just compensation that fully covers all the anguish and suffering you and family have been subjected to are enhanced. Once again, it is critical to ascertain if your case is eligible for a compensation claim and you can only do this by having a consultation with a law firm that boasts of highly experienced and skilled lawyers.