Zofran has been facing lawsuits alleging a link between the nausea drug and birth defects. A new legal development includes Novartis Pharmaceuticals Corporation being named as a new defendant in personal injury lawsuits. Meanwhile, the state of Alabama is no longer allowing plaintiffs to file new lawsuits against Zofran.
What is Zofran?
Zofran (ondansetron) is manufactured by GlaxoSmithKline and used to treat nausea and vomiting in cancer patients and surgical outpatients. It was approved by the FDA in 1999 for these uses only, but GlaxoSmithKline sold Zofran for off-label prescription use (i.e. unapproved by the FDA) to treat morning sickness in pregnant women.
Women who took Zofran have filed lawsuits against GlaxoSmithKline after alleging that the drug caused their babies to develop severe birth defects, including:
- Inguinal hernia
- Facial dysmorphia
- Heart defects
Allegations claim that Zofran failed to warn patients and doctors about these risks on warning labels and neglected to seek FDA approval for the drug’s use with pregnant patients. GlaxoSmithKline also allegedly misrepresented test results from animal fetus trials as sufficient proof for the drug’s safety in human fetuses. This implies that GlaxoSmithKline didn’t sufficiently investigate Zofran’s effects on a human fetus and overall human safety.
Novartis named a Zofran defendant
Zofran lawsuit plaintiffs submitted a Master Long Form Complaint (MLFC) in May against GlaxoSmithKline and Novartis, a Swiss pharmaceutical company. Novartis was named as a defendant in the Zofran MDL because in March 2015 it assumed responsibility of sponsoring the drug’s New Drug Application (NDA) from GlaxoSmithKline. As the new sponsor, Novartis is responsible for maintaining and updating Zofran’s label information, including warnings.
An MLFC unifies the central allegations against the defendants shared among the individual lawsuits collected in a multidistrict litigation (MDL). An MLFC doesn’t ignore or invalidate other allegations from the lawsuits. Rather, an MLFC is created to promote efficiency and economy in pre-trial procedures.
Since the MDL’s plaintiffs allege a failure to warn about Zofran’s birth defect risk on its labeling, Novartis is now included as a responsible party in all injuring events that occurred after March 23, 2015. Lawsuits concerned with injuring events that occurred before then cannot sue Novartis as GlaxoSmithKline was originally responsible for sponsoring Zofran’s NDA.
This is not the first time Novartis was sued in the U.S. over claims of irresponsible behavior in managing drugs. In March, the U.S. Department of Justice filed a whistle-blower lawsuit alleging that Novartis participated in “sham” marketing events and paid illegal kickbacks to doctors as incentives for prescribing its cardiovascular drugs. This case follows a series of other related lawsuits against Novartis dating back to 2010.
No more Zofran lawsuits in Alabama?
A bill was rushed into Alabama law last year setting an October 2015 deadline for all new Zofran lawsuit filings. As a result, plaintiffs can no longer file Zofran lawsuits from Alabama against GlaxoSmithKline.
Prior to an October 30, 2015 deadline, more than 150 Zofran lawsuits were filed from Alabama alone. A 2013 Alabama Supreme Court ruling placed drug liability on innovating manufacturers—meaning that plaintiffs cannot sue manufacturers that create and sell generic forms of a brand-name drug. How this law affects Novartis’s liability in Alabama remains to be seen as it isn’t the innovating manufacturer but it was responsible for Zofran’s labeling between March and October 2015.
If you or someone you know took Zofran during a pregnancy that resulted in birth defects, you may be eligible for legal compensation. Consult with a verified Zofran Attorney to have your case reviewed.