Pre-emption After Supreme Court Ruling May Depend On How FDA Weighs Risk
While the Supreme Court's landmark ruling in Wyeth v. Levine dashes pharmaceutical industry hopes for broad protection from product liability lawsuits, it will not trigger any sea change in litigation. Instead, the opinion seems likely to maintain the status quo and restrict the situations in which companies can claim they provided adequate warning of a drug's risks
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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.