Product Liability Defense Favored By Industry Appears To Have Supreme Court Support
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.
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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.
Gilead disputed Campie FCA decision, Amgen challenged Repatha ruling, and Merck challenged "unclean hands" defense against damages. Patent and Trademark Office wants court to determine if its attorneys' fees should be covered by patent applicants challenging its decisions.
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.