US FDA Takes Star Turn In Recent Product Liability Lawsuits
Agency’s direct involvement in pharma product liability litigation is one of the most striking developments in the field over the past year. Chart of 16 cases in multidistrict litigation shows status of settlements and upcoming bellwether trials.
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GSK and Sanofi will continue to defend against all claims alleging ranitidine increased risk of cancer. Four Rx generic firms reach settlements in first case scheduled for trial. Former US OTC Zantac marketers GSK and Sanofi, which markets the Zantac OTC brand in the US, along with former Rx brand marketer Pfizer could pay $1bn to $2bn each in potential settlements, analyst predicts.
GlaxoSmithKline will continue to defend itself against all claims alleging ranitidine increased the risk of cancer. Four generic firms reach settlements in the first case that had been scheduled for trial. GSK, Sanofi and Pfizer could pay $1bn-$2bn each in potential settlements, an analyst predicts.
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.