US FDA Takes Star Turn In Recent Drug Ingredient Liability Lawsuits
Interjection In Zantac MDL Is Agency's Second In Past Year
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.
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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.
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.
FDA requests immediate removal of ranitidine OTC and Rx drugs after third-party testing finds contaminant NDMA increases during storage, especially at higher temperatures. CDER Director Janet Woodcock asks firms to reformulate products to be stable as the ingredient remains approved.