Zofran Birth Defects Lawsuit No April Fools Prank

Birmingham, ALA new Zofran birth defects lawsuit, filed on April 1 in Alabama, is no April Fools prank and no laughing matter. The plaintiff in the case, Julie Hunter, asserts that the anti-nausea medication developed by GlaxoSmithKline (GSK) and originally approved by the US Food and Drug Administration (FDA) for use in cancer patients following chemotherapy, has no place in the treatment of morning sickness for pregnant women.

Hunter knows the tragic outcome firsthand. According to court documents, the Alabama woman took Zofran while pregnant in January 2006. Following the birth of her son Talon in August of that year, various doctors identified what were described as a myriad of birth defects deemed not to have been congenital in nature due to testing performed on both parents.

As a result, it is alleged that the various birth defects found in Talon are Zofran birth defects, based on the use of Zofran by his mother for that brief period in January 2006 during the first trimester of her pregnancy.

While the specific defects were not identified in the Hunter case, the use of ondansetron or ondansetron hydrochloride (Zofran) during pregnancy has led to heart defects and kidney malformations in some newborns. Both the FDA and GSK note that Zofran was never approved for use during pregnancy, and GSK has stated that the safety of Zofran use within the context of pregnancy has not been defined.

However, it should be noted that doctors and physicians have always held the legal and professional right to prescribe drugs to patients “off-label” - for indications not originally carrying FDA approval - based on their medical and professional opinion that a patient could benefit from the medication. During pregnancy, nausea (morning sickness) can be severe for some women, fostering vomiting, dehydration and weight loss. Zofran has been found to be extremely effective in controlling nausea. That said, in spite of research that keeps the risk for Zofran birth defects on the proverbial fence, there are those who feel there is a lack of information available as to the potential for birth defects, and that some doctors are operating in a vacuum.

What’s more, GSK was previously accused by the US Department of Justice of promoting various products in its pharmaceutical portfolio off-label. While doctors have the authority to prescribe off-label, it is illegal for manufacturers to promote drugs for indications not approved by the FDA. GSK settled with the feds for $3 billion without having to admit to any wrongdoing.

One of the drugs alleged to have been promoted off-label by GSK was Zofran.

This most recent Zofran birth defects lawsuit is Julie Hunter and Talon Hunter v GlaxoSmithKline et al, Case No. 2:15-cv-00544-JEO, in the US District Court, Northern District of Alabama.