STORY FROM: Drugs & Medical Devices

Federal Judges May Decide ‘Clear Evidence’ Question, High Court Rules

WASHINGTON, D.C. — Federal judges may decide whether a drug maker has presented “clear evidence” that the Food and Drug Administration would have rejected changes to a drug’s label, thereby barring a plaintiff’s failure-to-warn claim as preempted, the U.S. Supreme Court has ruled.

In a May 20 opinion written by Justice Stephen Breyer, the high court overturned a federal appeals court’s determination that the question cannot be decided on a motion for summary judgment and must be resolved by a jury.

The Judicial Panel on Multidistrict Litigation created an MDL docket in the U.S. District Court for the District of ...

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