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Novartis named as Defendant in Zofran Birth Defects Lawsuit

Jun 30, 2016

Novartis Pharmaceuticals has been named alongside GlaxoSmithKline in litigation over the anti-nausea medication Zofran. Some 250 lawsuits were consolidated in the U.S. District Court of Massachusetts alleging the drug makers illegally promoted Zofran off-label for morning sickness, leading to birth defects. On May 31, 2016 a Master Long Form Complaint named Novartis, as well as GSK, as Defendants; the form unifies similar allegations between the lawsuits.

Zofran was approved in 1991 for severe nausea, such as in patients undergoing cancer treatment. Plaintiffs allege that GSK marketed Zofran for morning sickness. Marketing a drug for an unapproved use is referred to as "off-label marketing". Physicians can prescribe drugs off-label, but it is illegal for pharmaceutical companies to promote it.

GlaxoSmithKline was the New Drug Application (NDA) sponsor when Zofran was approved, and therefore responsible for testing, marketing and properly labeling the drug. Additionally, the company was responsible for conducting post-marketing surveillance in order to monitor side effects.

In March 2015, Novartis bought GSK's oncology division and gained the right to sell Zofran in the US. As the new NDA sponsor, Novartis "became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States" the Master Long Form Complaint states. GSK continued to manufacture the drug.

Allegedly, "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."

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