Zofran usage, birth defects and lawsuits
Zofran side effects
As adults, we accept certain consequences when we take prescription medication. We understand that even highly effective drugs can have some unpleasant side effects, like drowsiness, sleeplessness, and weight gain.
But when our medications turn out to have dangerous side effects on others – that’s simply not right.
And for unborn infants to develop birth defects when we take “safe” medications – that’s more than just wrong. That’s a grave injustice that demands immediate action.
The makers of the anti-nausea medication Zofran have committed exactly this injustice.
What is Zofran?
Zofran is an anti-nausea medication manufactured by the gigantic pharmaceutical conglomerate GlaxoSmithKline. It is most commonly prescribed to patients who are undergoing chemotherapy.
Zofran alleviates the discomfort of nausea. That’s it. Not that nausea isn’t unpleasant, but it’s not a high-risk or life-threatening condition, even when it’s at its worst.
And, given the choice, no one in their right mind would sacrifice the health of their child for the sake of nausea relief.
Yet that’s what many people did – unknowingly – when they took Zofran while pregnant.
Zofran is a member of a class of medications that is known as 5-HT3 receptor antagonists. It works by reducing the effects of a substance in the body that is known as serotonin. Serotonin is known to cause nausea and ultimately vomiting and since many women get morning sickness during pregnancy, Zofran was prescribed. Zofran has been on the market for more than 20 years, but unfortunately the drug was never adequately tested or FDA approved for use by pregnant mothers. The FDA originally approved the drug in the United States in 1992, for use in post surgery nausea and by cancer victims. Despite lack of testing and approval, the manufacturer of Zofran, GlaxoSmithKline, marketed this drug to women who were pregnant and made millions of dollars selling their drug to this unapproved market. .
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Zofran and birth defects
GlaxoSmithKline’s Zofran has been linked with a number of serious and potentially fatal birth defects in infants. These birth defects include:
• Atrial Septal Defect, or “hole in the heart”
• Ventricular Septal Defect (a hole between two chambers of the heart)
• Heart murmur
• Cleft lip
• Cleft palate
ª Club foot
• Kidney diseases
• Fetal growth restriction
Every single one of these conditions presents serious health problems for your child.
• In babies with Atrial Septal Defect (ASD), a perforation in the heart allows oxygen-rich blood from one heart chamber to mix with the oxygen-poor blood of an adjacent heart chamber. This means that the heart and the lungs have to work extra-hard to keep up, and that can eventually lead to serious damage in the lung arteries.
• The situation for babies with Ventricular Septal Defect (VSD) is similar to that of babies with ASD – it’s just that the hole in the heart is in a different location. In babies with VSD, too, the heart and lungs have to work especially hard, and that can cause long-term arterial damage.
• A heart murmur indicates that some function of the heart is not working 100% correctly. There are several types of heart murmurs, and some of them are harmless. “Innocent murmurs” are very common in newborns, and often disappear over time.
Abnormal heart murmurs – the kind that are associated with Zofran – can indicate malformed heart valves or infection, both of which are potentially life-threatening conditions.
• Cleft lip is a condition in which a fetus’s facial features are not formed correctly. The resulting gap in the lip can create difficulties with eating, speaking, and hearing. Cleft lips are also associated with dental problems and ear infections, and often require difficult surgery to correct.
• Cleft Palate is a condition similar to cleft lip, in which the roof of a fetus’s mouth does is malformed. Children with cleft palates can also have difficulty eating, speaking, and hearing, and have higher rates of dental problems and ear infections.
• Club foot is a birth defect in which a foot is malformed so that it appears to “roll” at the ankle. Club foot can be treated with non-invasive methods, but serious cases can require surgery.
• Zofran has been linked with a number of kidney disorders, including malformed kidneys and blocked kidney passages.
• Zofran has also been linked with a condition called Fetal Growth Restriction, in which a fetus is prevented from reaching a full and healthy birth weight.
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Why would a doctor prescribe Zofran to pregnant women?
Odds are your doctor was no more aware of the dangers of Zofran than you were. That’s because, as usual, Big Pharma has been pulling the wool over their eyes, too.
GlaxoSmithKline knew very well that Zofran was dangerous, even potentially fatal, to fetuses and infants. They just never told us about it.
Zofran isn’t only for chemotherapy patients. It’s been prescribed many times for other forms of nausea. It’s never been officially approved to treat the morning sickness that’s associated with pregnancy … but that didn’t stop GlaxoSmithKline from aggressively marketing Zofran for just that purpose.
GlaxoSmithKline saw the profit potential in Zofran, so it spent millions to promote Zofran as a safe, reliable treatment of morning sickness.
With that decision, GlaxoSmithKline destroyed the lives of countless infants, parents, and families.
This corporation – one of the biggest of the big in the industry we now know as Big Pharma – put profits before people and pushed Zofran on doctors, patients, and expectant mothers …
In 2012, the FDA ordered GlaxoSmithKline to pay $3 billion for unethically promoting Zofran for the treatment of morning sickness. But the drug remained on the market.
That’s when the lawsuits started mounting up.
In 2016, GlaxoSmithKline field a motion to dismiss the lawsuits filed against it for promoting this dangerous drug to expectant mothers and their doctors. The motion was denied.
And now the floodgates are open. The time is right for a case against the makers of Zofran.
If the health of your child has been compromised by Big Pharma’s greed, we can help you achieve the significant financial compensation to which you may very well be entitled.
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The attorneys of TheLawFirm.com believe that Zofran is the cause of a great many birth defects – period.
The unethical practices and the heartless greed of Big Pharma companies like GlaxoSmithKline have gone on for far too long, and they harmed too many innocent people. Even fetuses and infants have paid dearly for this industry’s endless thirst for profit.
Zofran and GlaxoSmithKline have been brought to trial numerous times, but, as yet, there’s been no definitive, benchmark decision in this important case.
At TheLawFirm.com, we believe that the time is right to re-balance the scales of justice. We want to help you earn the compensation that you and your child are entitled to.
Zofran Lawsuit and trial Updates
GSK Claims It Can't Find Documentss In Zofran MDL
March 20, 2018
In yet another example of a multibillion dollar corporation entrusted with developing, manufacturing, and distributing the pharmaceuticals taken by millions of people being somehow unable to keep track of its own internal documents and communications, attorneys for drug maker GlaxoSmithKline (GSK) reported to a federal judge on March 14 that—after eight months of searching—they still have been unable to locate important documents relating to the company’s drug Zofran, presently the subject of multidistrict litigation (MDL) in a Massachusetts federal court. The antiemetic drug Zofran is alleged to have caused birth defects in pregnant women.
With the Zofran MDL still in the discovery stages, plaintiffs had sought records relating to approximately 40 marketing partnerships GSK entered into with regards to Zofran. Plaintiffs believe that the written contracts behind these partnerships may contain evidence to support their claim that GSK improperly urged the marketing of Zofran for off-label purposes, including as a treatment for morning sickness.
According to the U.S. Food and Drug Administration (FDA), Zofran (ondansetron) belongs to a class of medications known as 5-HT3 receptor antagonists. These drugs work to prevent the onset of nausea and vomiting from chemotherapy or radiation therapy by impeding the functioning of serotonin in the body. However, it is alleged by families in the MDL that the drug also was marketed for the unapproved purpose of helping pregnant women deal with morning sickness.
In addition to expressing dismay that the pharmaceutical giant was unable to produce a single contract relating to the 45 marketing partners named in their request for documents, attorneys for plaintiffs also have argued that GSK delayed unreasonably in providing documents in response to an off-label marketing probe conducted by the U.S. Department of Justice in order to render them unavailable in time for use in the MDL.
The Zofran MDL has been ongoing since 2015 and still had over 400 active cases remaining as of mid-February..
August 28, 2017
A federal judge in Massachusetts has mostly denied plaintiffs’ attempts to procure and use in a trial foreign regulatory files pertaining to GlaxoSmithKline’s anti-nausea drug Zofran, over which they are suing the drugmaker on claims that it causes birth defects.
August 1, 2017
Several plaintiffs who are suing GlaxoSmithKline (GSK) over the alleged links between its anti-nausea drug Zofran and birth defects have requested that the judge in the case force the company to produce foreign regulatory files concerning the drug.
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A study performed in 2012 found that there was no link between nausea and birth defects but instead chanced upon a potential connection between birth defects and the medicines used to treat nausea (drugs like Zofran):
How does the claim process work for my child?
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Our attorneys will never ask your family for money up front. We will advance all the costs of the claim and we only get paid if we win for you. This is called a contingency fee.
If you agree to have us review the claim we will obtain your child’s medical records and review them. If your child has a claim, you, the parent have control over the claim and make the decisions for your child.
Most claims can be resolved without you or your child ever having to testify or travel to court. The defect attorneys at TheLawFirm.com do the heavy lifting. Call now to speak with an experienced legal professional for free.
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