The drugmaker didn’t have the requisite “newly acquired information” regarding an optimal Pradaxa blood concentration level that could have warranted a unilateral change to the drug’s approved label, the U.S. Court of Appeals for the Fourth Circuit said.
Betty Knight suffered serious gastrointestinal bleeding in May 2013 after using Pradaxa for 18 months. She died in September 2013.
A jury in the Southern District ...
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