US District Judge F. Dennis Saylor organized discovery into five phases on Nov. 10 In Re: Zofran (Ondansetron) Products Liability Litigation, MDL No. 2657 in the District of Massachusetts.
About 300 lawsuits have been filed against GlaxoSmithKline LLC, based in Wilmington, DE, since the MDL was formed by the Judicial Panel on Multidistrict Litigation on Oct. 13, 2015.
Phase 1 — Product identification fact sheets, plaintiff fact sheets and defendant fact sheets must be released as required by MDL orders 10, 11 and 12 dated May 26, 2016.
Phase 2 — Electronically stored information relating to whether Zofran causes birth defects and injuries alleged, and all potential preemption issues must be released. Phase 2 is likely to require expert and fact discovery.
Phase 3 — Beginning immediately, this phase will cover general causation issues and whether any FDA approval or other action preempts any of theplaintiff’s claims.
Phase 4 — To star on Feb. 1, 2017 will consist of discovery concerning individual causation, product identification or damages.
Phase 5 — Beginning at a date to be determined, this phase will covery any remaining potentialy relevant issues.
According to Zofran complaints filed:
GSK knew about birth defects
Defendant GlaxoSmithKline LLC d/b/a GlaxoSmithKline GSK knew as early as 1992 that Zofran passed through the placenta and into a developing fetus and presented “unreasonable risk of harm” to developing babies.
GSK marketed Zofran “off-label” for treatment of nausea and vomiting associated with pregnancy. The company represented that Zofran was a safe and effective treatment for the nausea and vomiting associated with pregnancy. However, the drug had not been studied for its adverse affects upon pregnant mothers, or the possible teratogenic effects upon their fetuses at any time between 1991 and 2011.
Between April 2009 and December 2013, GSK reported that it made paid doctors and healthcare institutions more than $437.9 million dollars in the United States for speaking fees, consulting fees, research, travel fees and meals.