Product Liability: Discussions With FDA Remain Key In Defeating State Tort Suits
US Supreme Court says judges, not juries, should decide if FDA would have rejected additional label warning; Merck appears to have the support of three justices who note FDA's position that it decided not to require a change to Fosamax labeling.
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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.
US FDA's rejection of Merck's proposed Fosamax label warning preempts state-law tort suits, several Justices appear to conclude, as Kagan and Sotomayor question whether the proposal focused on the right risk.
Product Liability Returning To Supreme Court With Government, Former FDA Officials On Opposite Sides
US government supports Merck, saying FDA labeling decision preempts Fosamax failure-to-warn claim. Joshua Sharfstein and two other former FDAers argue Merck sought warning on a lesser injury.