Over 250 families have filed suit against GlaxoSmithKline, claiming the company’s anti-nausea drug Zofran, a common off-label treatment for morning sickness, causes birth defects. While the litigation began as a disparate collection of lawsuits filed in numerous district courts, the legal claims have now been consolidated in the US District Court of Massachusetts.
On May 31, 2016, plaintiffs’ attorneys filed a Master Long Form Complaint, unifying the numerous allegations that each family’s lawsuit shares. Of particular note is that, alongside GlaxoSmithKline, Novartis Pharmaceuticals Corporation has also been named as Defendant.
Novartis Becomes Zofran’s NDA Sponsor In 2015
Zofran was approved in 1991 and, in regulatory parlance, GlaxoSmithKline served as the drug’s New Drug Application (NDA) sponsor. As such, Glaxo was responsible for testing, marketing and properly labeling Zofran, along with maintaining a post-marketing vigilance program to monitor the drug’s safety after it entered the real world.
The situation changed on March 23, 2015, when Novartis, a Swiss pharmaceutical company, purchased GlaxoSmithKline’s oncology division, including the right to sell Zofran in the US. At that time, Novartis became the NDA sponsor of Zofran, and thus took on the responsibility of maintaining the drug’s labeling, including warnings. GlaxoSmithKline continued to manufacture the brand name product, but Novartis, according to the Master Complaint, “became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States.”
But the crux of the issue lies in another of Plaintiffs’ allegations: that GlaxoSmithKline unlawfully promoted Zofran for use as a morning sickness treatment without FDA approval. In purchasing Glaxo’s oncology business and, along with it, the right to sell Zofran, Plaintiffs claim 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.”
As per the Brand Master Complaint, Novartis will only count as a Defendant for parents who have filed suit in relation to alleged injuries occurring after March 23, 2015. Citing multiple epidemiological studies, parents say Zofran can increase the risk for congenital heart defects and cleft palate.
Master Complaint vs. Short Form Complaint
On its own, the Master Complaint is not a legally-binding document. Only after a family has filed an additional Short Form Complaint, providing information specific to their own situation, will they also formally “adopt” the allegations set forth in the Master Complaint. As the Complaint itself states:
“this Brand Master Complaint is intended to serve the administrative functions of efficiency and economy by presenting certain common claims and common questions of fact and law that generally pertain to the Plaintiffs adopting this Complaint. This Master Long Complaint does not necessarily include all claims asserted in all of the transferred actions to this Court. It is anticipated that individual Plaintiffs will adopt this Brand Master Complaint and selected causes of action herein through the use of a separate Brand Short Form Complaint. Any separate facts and additional legal claims of individual Plaintiffs may be set forth as necessary in the Short Form Complaint filed by the respective Plaintiffs.”
A second Master Complaint has been created for families filing suit over generic versions of Zofran’s active ingredient, a chemical called ondansetron. The Brand Master Complaint will, however, apply for parents who claim they took generics manufactured or sold by GlaxoSmithKline and Sandoz, a company that served as GlaxoSmithKline’s authorized generic distributor between 2007 and 2008.