Lawsuits alleging the anti-nausea medication Zofran caused birth defects have been consolidated in the U.S. District Court of Massachusetts. Reportedly, some 250 lawsuits have been filed against GlaxoSmithKline. In a Master Long Form Complaint filed on May 31, 2016, Novartis Pharmaceuticals Corporation was also named as Defendant. The Master Long Form Complaint unifies the common allegations between the lawsuits.
The U.S. Food and Drug Administration (FDA) approved Zofran in 1991. At the time, GlaxoSmithKline was the New Drug Application (NDA) sponsor and thus responsible for testing, marketing and properly labeling the drug. GSK was also responsible for conducting post-marketing surveillance in order to monitor side effects.
Novartis became involved in March 2015, when it purchased GSK’s oncology division. As such, Novartis gained the right to sell Zofran in the US and became the NDA sponsor. According the Master Complaint, Novartis “became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States.” when it became the NDA sponsor. The drug was still manufactured by GSK.
The plaintiffs in the litigation allege that GSK promoted Zofran for morning sickness, when the FDA had only approved it for severe nausea such as in patients undergoing cancer treatment. Marketing a drug for a non-FDA approved use is known as off-label marketing. The lawsuit alleges that “Novartis gained knowledge of the false and misleading promotion of Zofran for treating pregnancy-related nausea, sometimes referred to as morning sickness, and of the risks of prenatal exposure to Zofran. Novartis had a duty and continues to have a duty to warn adequately and to correct GSK’s misrepresentations and has failed to do so.”