Those who are just now hearing about the growing controversy mounting over Zofran may not be aware of the medication’s storied history and the lengths that its maker went to in order to profit illegally off of its use as a treatment for morning sickness in the first trimester of pregnancy. GlaxoSmithKline has since settled disputes regarding unethical business practices and the marketing of numerous dangerous medications and paid over $3 billion in civil and criminal fines.
Families of children who have been impacted by Zofran are now beginning to file claims and lawsuits against the company. The Zofran birth defect attorneys at Rosenfeld Injury Lawyers are dedicated to providing the victims with information about injuries caused by Zofran, pending litigation, their rights and whether they may be able to pursue a Zofran birth injury lawsuit.
What is Zofran?
Zofran [Ondansetron (INN)] is a medication that was developed in the 1980s for the treatment of nausea commonly caused due to surgical procedures or cancer treatments such as chemotherapy. It received approval by the FDA in January of 1991 for the specific purpose of treating nausea in postoperative patients or those undergoing radiation and chemotherapy treatments. The medication was not intended for use in pregnant women and the FDA classified it in pregnancy category B— a designation for medications where there was inadequate research available to determine whether the drug could cause harm to unborn children.
Some reports suggest that GlaxoSmithKline knew by 1992, however, that the drug posed significant risks as a possible treatment for morning sickness in pregnant women throughout their first trimester. Despite this knowledge, the company saw bountiful opportunity in marketing Zofran as an aid to treat the most severe forms of nausea caused by morning sickness. It would be challenging for GlaxoSmithKline to gain approval from the FDA, so the company chose to find a loophole instead.
Off-Label Prescriptions Written for Zofran Related to Morning Sickness
The maker of Zofran may have suspected that the FDA would turn down approval of Zofran as an explicit treatment for morning sickness, so the strategy was instead to offer incentives to doctors to offer it as an off label treatment instead. Doctors are permitted to prescribe medication for uses other than what the drug is specifically designed or intended and this is how GlaxoSmithKline was able to market Zofran without getting the FDA approval normally required. Doctors became complicit in the plan because they were offered special kickbacks for prescribing the medication but they were also provided misleading and ambiguous statements regarding the safety of the medication and its risks when prescribed to pregnant women.
Zofran is not the only drug that GlaxoSmithKline marketed fraudulently as proven by a settlement agreed to in 2012 for $3 billion in civil and criminal fines. This settlement was for unethical and illegal marketing practices related to numerous medications— which included Zofran. Since then, victims have begun to build cases against GlaxoSmithKline as new studies link Zofran to numerous congenital birth defects and severe medical conditions.
Birth Defects and Conditions Caused by Zofran Usage
It was found that women who used Zofran were 30% more likely to deliver a child with some form of birth defect and almost five times as likely to deliver a baby with heart disease. The types of defects and medical conditions with links to Zofran use include the following.
- Heart defects— children exposed to Zofran have exhibited deformities in their hearts that include holes between the walls of the aortic and ventricular valves. Heart disease is the most common condition associated with Zofran use and victims must often undergo surgical procedures and remain on medications for their entire lives. In the worst cases, the defect is so severe that the child requires a transplant or dies from heart failure.
- Cleft palate and lip— it was found that children were more likely to suffer from cleft palate or lip if they were exposed to Zofran in the womb. Cleft palate is the result of a hole in the roof of the mouth that allows fluids and air into the sinus cavity and cleft lip is a visible hole in the lip that requires surgical repair. Both conditions can lead to severe complications if not treated and require multiple surgeries and extensive therapy to overcome.
- Kidney defects— reports of malformed or missing kidneys are more common in children exposed to Zofran in the womb than those who were not. Renal failure— or the inability of the kidneys to function— can result in the failure of other organs such as the heart or the lungs due to blood toxicity. The only treatments available for renal failure are regular dialysis or kidney transplants.
- Club foot and hand— this deformity occurs when one hand or foot does not form properly and is physically twisted or bent in an abnormal position. Physical therapy and surgery are often required to correct the condition and because one foot or hand is normally larger than the other, it can impact growth, development and the ability to run and walk.
- Brain defects— since Zofran is prescribed during the first trimester and has a marked impact on development; it is no surprise that there is a correlation between its use and reports of brain damage. The brain begins to form during the first trimester, right when Zofran use would be heaviest.
- Premature death— the defects and conditions that are caused by Zofran use during pregnancy result in severe complications and despite the best efforts of medical professionals, children affected by the drug may die before or during birth or prematurely due to complications related to their congenital defects.
Get Help Now For Your Child's Birth Defects. Rosenfeld Injury Lawyers is Actively Pursuing Zofran Lawsuits
Families of children impacted by Zofran use have begun to bring lawsuits against GlaxoSmithKline for its negligent marketing of the medication without FDA approval. If you believe that Zofran is the cause of your child’s birth defects or injuries, contact Rosenfeld Injury Lawyers today to learn more about pending Zofran litigation and to have your case evaluated by an experienced prescription drug litigation attorney. We will perform a thorough investigation into the cause of your child’s injuries and let you know what legal options you have as well as what you could expect if you decided to pursue a lawsuit against Zofran manufacturers.
Based in Chicago, our law firm is accepting Zofran cases from across the country. If for any reason, we are unable to secure the compensation that you need and are entitled to, our services will be without charge.
For additional information on Zofran lawsuits visit our FAQ page.