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US FDA Is Pulled Into Zofran Product Liability Litigation

Executive Summary

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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GSK Loses Bid To Get US FDA To Change Zofran Label, But May Prevail On Preemption Defense Anyway

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.’

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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