US FDA Is Pulled Into Zofran Product Liability Litigation
Agency officials meet with GSK and plaintiffs' steering committee in wake of GSK citizen petition; judge asks FDA to resolve petition 'expeditiously' as it could impact resolution of preemption dispute and the outcome of the litigation alleging Zofran caused birth defects.
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In granting GlaxoSmithKline’s motion for summary judgment in multidistrict litigation, judge notes FDA rejected requests to change warning label about use in pregnant women multiple times and would not have approved warnings sought by plaintiffs.
Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year; 16 cases in multidistrict litigation listed in chart showing status of settlements and upcoming bellwether trials.
Agency denies GlaxoSmithKline’s citizen petition requesting review of information about Zofran’s use in pregnancy. But GSK says agency has ‘clearly communicated its position that birth defect warnings are not warranted for Zofran.’