Makers of Nausea Drug Sued Based on Birth Defect Claims
GlaxoSmithKline (GSK), makers of the drug with the brand name Zofran (also known as Ondansetron), have been subject to countless lawsuits nationwide for birth defects believed to have been caused by this drug. The drug Zofran was originally designed for the purpose of treating nausea in cancer patients undergoing chemotherapy. This was the use for which Zofran received FDA approval, and has been found very effective for this use. However, the drug gained a reputation as being so successful at treating nausea that physicians in the area of obstetrics and family medicine began to prescribe it for the off-label purpose of treating morning sickness in pregnant women. The term “off-label” indicates that the drug is being prescribed for a use not officially reviewed and approved by the FDA.
Prescribing drugs for off-label uses isn’t barred by the FDA, but companies manufacturing drugs that are commonly prescribed for off-label uses are not allowed to advertise a drug for a use that has not been approved by the FDA. Nevertheless, in 2012, the US Department of Justice filed several civil and criminal charges against GSK. The charges included promoting the off-label use of the drug for pregnancy-related nausea, and even for paying physicians to promote the drug for this purpose. GSK denied the claims of wrongdoing in regards to its promotion of Zofran, but nevertheless settled with the Justice Department for roughly $3 billion.
Several scientific studies have shown that using Zofran during the first trimester of a pregnancy can result in harm to the developing fetus. One study found that, among women taking Zofran, there was a greater likelihood that their child would be born with a malformed heart. Other mothers who took Zofran have been giving birth to a disproportionate number of babies with cleft palates, club feet, and skull deformities. A number of families in West Virginia have begun to file lawsuits against the drug maker to compensate them for the health problems their children now face which are believed to have resulted from the drug.
While nothing can completely eliminate the pain of having a child born with birth defects, you may be entitled to file a lawsuit to help your family afford the additional medical expenses and costs of living caused by the drug Zofran. Contact the Bayless Law Firm for a consultation on your claim with a compassionate and diligent personal injury lawyer in southern West Virginia. From anywhere in and around Princeton, West Virginia, including Spanishburg, Keystone, Athens, and throughout Kanawha and Mercer County, call 800-359-2356, or 304-487-8707.