GlaxoSmithKline is facing hundreds of lawsuits over their anti-nausea medication, Zofran, but it looks like they won’t have to face the lawsuits alone. In the plaintiffs’ Master Long Form Complaint, the plaintiffs accuse both GlaxoSmithKline and Novartis Pharmaceuticals Corporation of failing to warn doctors and patients of the risks associated with Zofran in pregnant women.
Zofran became popular as an off-label treatment for morning sickness in pregnant women. However, several epidemiological studies have found a link between fetuses exposed to Zofran in utero and birth defects such as cleft palates and congenital heart defects.
Since its approval in 1991, Zofran has been sold and marketed by GlaxoSmithKline until 2015, when Novartis bought the company’s oncology division. This included the right to sell and market Zofran in the United States. After hundreds of reports of birth defects, the first Zofran lawsuit was filed in February 2015, followed by the Master Long Form Complaint, filed this past month.
The Master Long Form Complaint claims that Novartis gained knowledge of the false and misleading promotion of Zofran when the company bought the division responsible for its manufacturing from GSK, but chose not to provide adequate warnings or correct GSK’s misrepresentations to the public.
Just last month, a conditional transfer order added over 200 lawsuits to the consolidated multi-district litigation in Massachusetts. In January, U.S. District Judge F. Dennis Saylor IV refused the defense’s bid to dismiss all claims in the multi-district litigation and stated the families deserved the chance to develop the facts against GlaxoSmithKline.
For hundreds of families whose children were born with birth defects from in utero exposure to Zofran, the road to holding GlaxoSmithKline and Novartis responsible will be a long one. Now that the Master Long Form Complaint has been filed, plaintiffs can now file Short Form Complaints that will take them one step closer to their day in court with Zofran’s manufacturers.