According to the Centers for Disease Control and Prevention (CDC), about one in every 33 babies born in the U.S. each year suffers from birth defects. Mothers who smoke or drink alcohol, who have certain medical conditions like diabetes, or who have a family history of birth defects are more at risk for giving birth to a baby with birth defects. Sometimes, however, certain medications prescribed during pregnancy can also increase risk—unbeknownst to the mother.
The Ohio Connections for Children with Special Needs (OCCSN) states that birth defects and congenital anomalies are one of the leading causes of infant death in the U.S., and result in about 19 percent of infant deaths in Ohio. Estimates are that in Pennsylvania, there are about 1,339 babies born each year with a heart defect—the most common cause of birth-defect-related infant death.
The West Virginia Birth Defects Surveillance System (BDSS) found that between 1990 and 1999, a total of 5,161 babies were diagnosed with one or more birth defects. Some of those defects may have been caused by Zofran (ondansetron), an anti-nausea drug often prescribed to treat morning sickness.
Though the drug was never approved by the FDA for such treatment, the manufacturer—GlaxoSmithKline (GSK)—aggressively promoted Zofran to doctors and pregnant moms, so that it soon became a bestselling medication for morning sickness. Unfortunately, many moms paid the price when they gave birth to babies suffering from birth defects.
The Pittsburgh attorneys at Chaffin Luhana are currently reviewing potential Zofran lawsuits. They stand ready to help families who have had their lives turned upside down because of birth defects potentially caused by the ingestion of Zofran.
Unsuspecting Pittsburgh Women Took Zofran for Morning Sickness
The FDA approved Zofran in 1991 for the treatment of nausea and vomiting in cancer patients. It was also approved to treat the same symptoms in patients going through radiotherapy or surgery. The drug was never approved for use in pregnant women for morning sickness or any other condition, but nevertheless, GKS advertised it for this use.
Though doctors may prescribe a drug “off-label” to treat a condition for which it was not approved by the FDA, it is illegal for manufacturers to advertise drugs for these purposes. The U.S. Department of Justice (DOJ) started investigating the GSK in 2004 because they had found evidence the company might be illegally marketing Zofran and other drugs.
Meanwhile, pregnant women were taking Zofran to help treat morning sickness were unaware of the potential dangers. By the year 2000, GSK had received at least 32 reports of birth defects linked with the use of Zofran. Since then, that number has climbed to at least 200. They never informed mothers or doctors about these reports, and continued to advertise Zofran as being a safe and effective treatment for pregnant women.
Though federal law requires drug companies to include warnings on their product labels as soon as they become aware of a hazard associated with the drug, GSK failed to revise Zofran’s labeling to disclose the potential for birth defects.
Department of Justice Fines GSK for Illegal Marketing of Zofran
In July 2012, the DOJ announced that GSK had agreed to plead guilty and pay $3 billion to resolve criminal and civil liability arising form their unlawful promotion of certain prescription drugs, including Zofran. They also entered civil settlements with the U.S. that included more than $1 billion in payments for illegal marketing. At that time, it became clear that GKS had made false representations about the safety of Zofran.
In the company’s written agreement with the United States, GSK settled claims that they had promoted the sale and use of Zofran for conditions other than which it was approved by the FDA, that they made unsubstantiated and false claims about its safety, and that they offered and paid illegal remuneration to health care professionals to induce them to prescribe Zofran.
What is Zofran?
Zofran belongs to a class of drugs called “5-HT3 receptor antagonists,” which block a neurotransmitter in the brain called “serotonin.” This neurotransmitter can trigger nausea and vomiting, so when the drugs block it, they help reduce these feelings in patients.
About 75 percent of women are thought to experience morning sickness during the beginning of their pregnancies. Mild forms cause no damage to the mother or the fetus, but severe forms (called “hyperemesis gravidarum”) can lead to weight loss and dehydration. Women experiencing this more severe form are often advised to see their doctors for solutions.
GSK made hundreds of millions of dollars each year advertising Zofran to women experiencing severe morning sickness, but many of those women are now pursuing Zofran lawsuits in an effort to recover damages after their babies were born with birth defects.
Animal Studies Raise Concerns About Zofran Birth Defects
Though GSK never conducted any studies with Zofran in pregnant women, early animal studies did raise some concerns. The company stated that the results of these studies showed no harm to the fetus, but the data revealed that Zofran could potentially be linked to premature birth, intrauterine fetal deaths, and incomplete bone growth. Some of the studies indicated the potential for congenital heart defects, as well.
Drugs often act differently in humans than in animals, but GSK failed to take their studies to the next step to be sure Zofran was safe to use in pregnant women. Even after they started receiving reports of birth defects, they ignored the data. These early reports linked Zofran most often with congenital heart defects, although other defects were also reported, including intrauterine death, orofacial defects, stillbirth, and severe malformations.
Later Studies Suggested Zofran Increased Risk of Birth Defects
In 2006, researchers discovered that Zofran could cross the placental barrier, meaning that mothers taking it could be potentially exposing their unborn babies to the effects of the drug. For the study, researchers tested 41 patients taking Zofran, collecting blood, amniotic fluid, and more for analysis, and found Zofran in all the samples.
“A significant amount of ondansetron was present in all embryonic compartments,” the researchers wrote.
More studies followed. In 2012, researchers analyzed data from over 10,000 women and found that treatments with drugs like Zofran were associated with a potential increased risk of cleft lip and palate and other neural tube birth defects, especially when the drugs were taken during the first trimester.
In 2013, a study from Australia also found a small increased risk of major birth defects in women taking Zofran during the first trimester. The researchers cautioned that Zofran might not be safe to use during pregnancy. The next year, researchers from Sweden found similar results: a significant increased risk for cardiovascular defects in babies born to women who took Zofran during early pregnancy.
Types of Zofran Birth Defects
Considering the studies on Zofran and similar drugs, along with the reports sent to the FDA and to GSK, women taking Zofran may be at an increased risk of giving birth to a baby with the following birth defects:
• Musculoskeletal anomalies
• Mouth deformities
• Cleft lip and palate
• Heart defects, including heart murmurs, atrial septal defect, and ventricular septal defect
These defects are serious and life-changing. In addition to affecting an infant’s young life, they can have long-term consequences. Compared to the general population, for example, adults with congenital heart defects have 3-4 times higher rates of emergency-room visits, hospitalizations, and intensive care unit stays, according to the Congenital Heart Public Health Consortium.
The FDA also warned in 2012 that Zofran could increase risk of heart rhythm problems and “serotonin syndrome,” in which the body stores too much serotonin, causing symptoms like confusion, rapid heart rate, muscle rigidity, diarrhea, and even seizures and unconsciousness.
In the U.S., Zofran remains a “Category B” drug, which means that no human studies have determined its safety in pregnant women. In Canada, the Product Monograph for Zofran warns women and physicians that the safety of Zofran has not been established, and that its use during pregnancy is not recommended.
Pittsburgh Zofran Lawsuits
Women who took Zofran and then gave birth to babies with birth defects are entitled to compensation. Many have filed Zofran lawsuits to hold GSK liable for failing to do a number of things to protect the public, including:
• Conduct enough studies to fully determine the safety and efficacy of the drug in pregnant women
• Provide adequate warnings about the risks associated with the drug
• Refrain from illegally advertising the drug for unapproved uses
• Reveal evidence linking Zofran with a potential increased risk of birth defects
• Properly evaluate early studies for evidence of potential harm to a fetus
Plaintiffs filing Zofran lawsuits also claim that GKS fraudulently advertised Zofran to pregnant women and paid doctors to prescribe it without fully informing them of the risks. Finally, they claim that Zofran is a defective drug, and should not have been released without the proper warnings and adequate safety studies.
Pittsburgh Zofran Lawyers Can Help
If you or a loved one has a child suffering from birth defects caused by Zofran, the attorneys at Chaffin Luhana LLP may be able to help. We have decades of experience dealing with drug companies who seem to put profits ahead of public safety. We will fully investigate your case and help guide you through your legal options. Should you decide to pursue a Zofran lawsuit with us, we will aggressively fight for your rights to compensation.
Mothers who took Zofran and then had babies with birth defects often say that they never would have taken the drug had they been aware of the risks. If you’re one of these mothers (or a concerned father), please call today for a free and confidential case evaluation at 1-888-316-2311.