Plaintiffs’ attorneys in the Zofran multidistrict litigation (MDL) currently underway in Boston have filed a Master Long Form Complaint (PDF) in an attempt to unify the numerous allegations that each family’s lawsuit shares. Of particular note is that alongside GlaxoSmithKline (GSK), Novartis Pharmaceutical Corporation is now named as a defendant in the litigation.
Free Confidential Lawsuit Evaluation: If your child or other loved one was born with a birth defect after the mother took Zofran during pregnancy, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.
What’s the Problem?
June 15, 2016 – Zofran (generic: ondansetron) was approved by the U.S. Food & Drug Administration (FDA) in 1991, and GSK served as its New Drug Application (NDA) sponsor. As such, the company was responsible for testing, marketing and labeling Zofran, in addition to establishing a postmarketing vigilance program to monitor the medication’s safety after it hit the market.
That all changed on March 23, 2015, when Novartis bought out GSK’s oncology division and became Zofran’s NDA sponsor. Novartis now owns the right to sell Zofran in the U.S., and is responsible for maintaining the drug’s labeling. GSK will continue to manufacture the brand name medication, but Novartis “became involved in the research, manufacture, testing, packaging, labeling, advertising, promoting, marketing, and selling of Zofran in the United States,” according to the Master Complaint.
The central allegation in Zofran lawsuits is that GSK unlawfully marketed Zofran for use during pregnancy as a morning sickness treatment without FDA approval. In purchasing GSK’s oncology division as well as the right to sell Zofran, plaintiffs now 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.”
However, according to the Master Complaint, Novartis will only be included as a defendant in complaints filed after March 23, 2015. Citing multiple epidemiological studies, plaintiffs allege that the maternal use of Zofran during pregnancy can increase the risk for a large number of congenital malformations including heart defects, cleft palate and clubfoot.
Do I Have a Zofran Lawsuit?
The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Zofran lawsuits. We are handling individual litigation nationwide and currently accepting new birth defect cases in all 50 states.
Free Confidential Case Evaluation: Again, if your child was injured by Zofran side effects, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.