Product Liability Returning To Supreme Court With Government, Former FDA Officials On Opposite Sides
Executive Summary
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.
You may also be interested in...
Merck Freed From Fosamax Product Liability Suits Based On US FDA Complete Response Letter
District court dismisses more than 500 cases alleging Merck failed to warn of the risks of its osteoporosis drug, following path set by US Supreme Court in its ruling on the litigation three years ago.
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.
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.