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US FDA Is Pulled Into Zofran Product Liability Litigation

 
• By Brenda Sandburg

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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FDA's response to citizen petition could determine the outcome of Zofran product liability litigation.

While the US Food and Drug Administration's actions on drugs are typically cited in product liability litigation, the agency does not play a direct role in these cases. But through the filing of a citizen petition, GlaxoSmithKline PLC has drawn the agency into multidistrict litigation alleging GSK failed to warn of the risk of birth defects with use of its antiemetic Zofran (ondansetron) during pregnancy.

The 1 November citizen petition led FDA to hold separate "listening meetings" with GSK and members of the plaintiffs'...

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