Every mother should be able to experience the birth of her baby with assurance that the infant will be as safe and healthy as possible. When this is taken away from you, it can shatter what is supposed to be a time of pure joy for a new mother and her family.
Zofran (a band name for the drug ondansetron) is a drug that is sometimes prescribed to help expecting mothers cope with the nausea and vomiting of morning sickness, even though the Food and Drug Administration has not approved it for the purpose. Studies have come out linking it to serious mental and physical defects in infants. This has traumatized many families, leaving mothers feeling angry, guilty and helpless.
You should be angry — but it is not your fault, and you are not helpless. The attorneys at Pierce Skrabanek represent families harmed by irresponsible pharmaceutical companies. Our Zofran attorneys know exactly how to fight back against them to seek compensation for the pain and suffering your family is going through.
Zofran was developed to help alleviate nausea and vomiting in people after chemo- or radiotherapy, and after certain surgeries. First approved for public consumption in 1991, the drug helps to alleviate these symptoms by blocking the flow of serotonin, a complex neurotransmitter, into the areas of the brain that cause them.
Despite not being approved to treat morning sickness, Zofran became a popular option to treat the condition. Although the drug did indeed reduce morning sickness, a number of studies suggest Zofran has been responsible for several congenital defects.
Today, Zofran’s manufacturer is being sued by mothers and families for compensation to cover the medical expenses, physical therapy and emotional trauma inflicted by the drug.
Studies have shown that infants who were exposed to Zofran during the first trimester of pregnancy are twice as likely to develop certain physical deformities. Another study found that women taking Zofran during their first trimester were more likely to have children with congenital heart defects.
Other birth defects that have been tied to Zofran are:
Congenital birth defects aren’t the only thing expecting mothers have to worry about when prescribed Zofran. The drug’s blockage of serotonin in certain areas of the brain can have serious side effects in users, including:
In addition, Zofran side effects may cause serotonin syndrome, which occurs when too much serotonin is in the body. This risk is higher when Zofran is mixed with certain other medications. Symptoms of serotonin syndrome can manifest as confusion or behavioral changes, seizures, high fever and more.
Users of Zofran may also develop QT Syndrome or Torsades de Pointes, conditions that affect the bioelectric rhythm of your heart and cause an erratic – and potentially fatal – pattern of heartbeats.
In 2012, the 32-mg intravenous Zofran dosage was recalled by the FDA after the drug was linked to a side effect called Torsades de Pointes, which is a heart rhythm disorder. However, a birth defect-related recall still has yet to be issued, and other versions of the product continue to exist on the market.
A monumental win in the fight against GlaxoSmithKline came when the company was forced to pay $3 billion in a settlement to the federal government for knowingly promoting Zofran and other drugs for off-label, unapproved use and paying doctors to prescribe the drugs, according to the U.S. Department of Justice.
As the largest health care fraud settlement in the country’s history, this was the first step in punishing the company for their unethical actions, but it won’t be the last. Families who have had their lives changed by Zofran are encouraged to help hold them accountable and make sure your family is compensated for the injuries and emotional stress you’ve experienced. You should speak with an attorney today to learn how we can help you do that.
It’s terrifying to think that a drug you were prescribed may be responsible for a condition that could affect your child for the rest of his or her life. If you’d had even a hint that Zofran was linked to congenital birth defects and heart defects, it’s likely that you would not have taken the drug, and your family would not be going through this traumatic crisis.
When we take a case, we make every effort and expend every resource to prove liability on the part of the drug’s manufacturer. We aim to prove that you were not properly warned of the drug’s risks, and that you deserve to be compensated.
Our legal team can fight to get you full compensation for:
Zofran is produced by GlaxoSmithKline, a pharmaceutical company based in England.Formed in 1935, GlaxoSmithKline (GSK) is the sixth-largest manufacturer of pharmaceutical products in the world. GlaxoSmithKline has faced very serious criminal charges and civil lawsuits over the past decade, and has had to settle or pay over allegations of intentional off-label marketing, as well as suppression of negative research related to their products.Some of these verdicts include a $2.5 million settlement for fraudulent marketing of the antidepressant Paxil, and a $750 million fine as a result of intentional manufacturing of defective products in a subsidiary based in Puerto Rico.
Warnings have been issued by the FDA about certain complications associated with taking Zofran, including a heightened risk of heart problems.
Medical studies have suggested that pregnant women taking Zofran are at a higher risk for giving birth to infants with physical and mental defects, such as cleft palate, skull deformity and mental disabilities.
So far, the lawsuits that have been filed against Zofran remain pending. Pharmaceutical litigation is complex, but our attorneys won’t stop fighting until each case we handle has been resolved.