GlaxoSmithKline, a major pharmaceutical manufacturer, is facing several lawsuits due to their anti-nausea medication Zofran. Product liability attorneys and the victims in these Zofran birth defect lawsuits allege that the drug company failed to warn the medical community about the risk of serious birth defects associated with using Zofran during a woman’s first trimester.

Overview of Zofran

Zofran, generically known as ondansetron, was approved by the FDA in the early 1990s. The FDA approved the drug to treat severe nausea in patients receiving surgical anesthesia and to reduce vomiting in patients receiving cancer therapies.

Zofran has not been approved by the FDA to treat morning sickness and according to several Zofran lawsuits, GlaxoSmithKline has never studied the effects of Zofran on pregnant women and their unborn children. Although doctors are allowed to prescribe medications for off-label uses (non-FDA approved uses), it is illegal for drug manufacturers to promote or advertise their medications for off-label uses.

Zofran Birth Defects

Several studies have found an association between pregnant women using Zofran and increased risks of birth defects, especially when the medication is taken during the first trimester. European studies have found a connection between Zofran and an increased rate of congenital heart defects in children exposed to the medication before birth.

Studies performed in the United States at Harvard and Boston University found that exposure to the active ingredient in Zofran made it twice as likely for a child to be born with a cleft palate. A cleft palate occurs when there is not enough tissue in an unborn child’s mouth or lip area, and the tissue is unable to properly join together.

Despite these findings, the U.S. Food and Drug Administration recently rejected a petition to change Zofran’s drug category, saying in an October 2015 statement that these studies “do not support a determination that there is an increased risk of fetal adverse outcomes.”

Zofran Lawsuits

The Zofran lawsuits brought against GlaxoSmithKline claim that the company illegally promoted the drug for off-label uses.

In 2012, GSK settled a federal, civil false claim lawsuit alleging GSK had promoted Zofran for the treatment of morning sickness in pregnant women despite being approved only for post-operative nausea, and that GSK had paid doctors kickbacks for prescribing Zofran. In 2012, GSK settled that lawsuit along with three similar lawsuits regarding other GSK products for $1.043 billion.

At least 7 families have come forward to file a Zofran lawsuit against the major pharmaceutical company, and personal injury attorneys expect many more cases to be filed in the near future. These birth defect lawsuits claim that GlaxoSmithKline violated consumer protection laws and likely assert claims for negligence, fraud and misrepresentation, breach of contract, and strict products liability.

Awards and settlements from Zofran lawsuits will help families pay expensive medical bills as well as compensate victims for the pain and suffering they endured.

Potential plaintiffs may have the option of bringing a lawsuit individually or as a member in a Zofran class action lawsuit. Plaintiffs bringing individual lawsuits often have more autonomy and control over their case, while class action lawsuits share the costs of litigation among all the members. This is a decision that should be made on a case-by-case basis with the advice of a legal professional.