Drug manufacturer GlaxoSmithKline is facing more than 200 lawsuits alleging that anti-nausea medicine Zofran has caused serious birth defects when used to treat vomiting and nausea in pregnant women. Product liability attorneys have filed lawsuits across the country, although as of Nov. 16 112 cases had been transferred to or filed in the U.S. District Court of Massachusetts. Among those transferred: Several lawsuits previously filed by Chicago birth injury lawyers in the U.S. District Court for Illinois.
Allegations of Zofran-Connected Birth Defects
Zofran, which is also known by its generic name of ondansetron, is a serotonin 5-HT3 receptor antagonist. It is used to treat vomiting and nausea caused by chemotherapy, radiation therapy, surgery and gastroenteritis. The drug was developed by manufacturer GlaxoSmithKline in the 1980s. Since its U.S. patent expired in 2006, generic versions of the drug are also available.
The drug is often prescribed to pregnant women who are suffering morning sickness. In fact, an estimated one million American women annually use the drug. Because the U.S. Food and Drug Administration never approved the drug for use in pregnant women, this is considered “off label.” It is both legal and common for doctors who are familiar with the drug to prescribe a drug for off-label usage. However it does entail some risks because the manufacturer hasn’t conducted studies and clinical trials to fully understand the potential risks associated with using the drug to treat off-label conditions. It is, however, illegal for a drug manufacturer to market the drug for off-label usage without FDA approval.
In 2012, GlaxoSmithKline agreed to pay $3 billion in fines and to plead guilty to criminal charges that it illegally promoted the off-label use of certain drugs, including the use of Zofran by pregnant women.
Parents of children born with birth defects following the use of Zofran allege that the drug is responsible for:
- Atrial Septal Defect (ASD)
- Ventricular Septal Defect (VSD)
- Heart mumurs
- Cleft lips
- Cleft palettes
- Kidney defects
- Musculoskeletal abnormalities
- Fetal growth restriction
- Fetal death
In December 2014, The Toronto Star published an article “Birth Defects Blamed On Unapproved Morning Sickness Treatment.” The article reported:
“Canadian women with severe morning sickness are being prescribed a powerful anti-nausea drug suspected of causing deformities in some babies, a Toronto Star investigation has found. The drug, ondansetron, is approved by Health Canada to treat nausea and vomiting in chemotherapy and surgery patients. It is not approved to treat pregnant women, but some doctors prescribe it ‘off label’ without hard proof it is safe for expectant mothers. So little is known about how ondansetron affects pregnant women that the drug manufacturer says such use is ‘not recommended’ for these vulnerable patients. At least 20 Canadian women treated with ondansetron for vomiting in pregnancy experienced serious suspected side-effects, including two infant deaths and multiple cases of newborns with heart defects and kidney malformations, according to a Star analysis of 2012 records.”
GlaxoSmithKline responded to the allegations, saying:
“The safety of ondansetron for use in human pregnancy has not been established. … [The company] monitors and reports all adverse event reports … and works closely with regulatory authorities … to include relevant safety information for physicians and patients within our product labels.”
Subsequent reports and studies indicated that Zofran increased the risk of heart defects by 62 percent. It’s also been alleged that GlaxoSmithKline knew or should have known about the risk of birth defects and issued warnings to doctors years ago.
Since these reports, the company has been hit with a number of personal injury and product liability lawsuits filed by the parents of children born with birth defects after their mothers used Zofran during pregnancy.
In October, federal judges decided to centralize the Zofran cases with a judge in the U.S. District Court of Massachusetts. This process, known as multi-district litigation, or MDL, centralizes the discovery process, ensures that pre-trial rulings are consistent from case to case, and can ultimately save money for the plaintiffs as well as GlaxoSmithKline.
The U.S. District Court of Massachusetts was selected because of the number of cases already pending before the court. It also had jurisdiction over GlaxoSmithKline’s $3 billion settlement in 2012.
Chicago Birth Injury Lawyers for Zofran Victims
If your child suffered birth defects following the use of Zofran during pregnancy, you may have grounds for a lawsuit against GlaxoSmithKline. The Chicago birth injury lawyers of Cogan & Power, P.C., have experience representing the victims of pharmaceutical malpractice. Call us today at (312) 477-2500 to schedule a free meeting with one of our lawyers. We’ll review the details of your situation and help determine whether you have grounds for a claim against the company.