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.
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In granting GlaxoSmithKline’s motion for summary judgment in multidistrict litigation, judge notes FDA rejected requests to change warning label about use in pregnant women multiple times and would not have approved warnings sought by plaintiffs.
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 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.