DDN Medical Affairs - A Dohmen Company

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Supreme Court Ruling on Generic Label Suits

On Thursday, June 23 the US Supreme Court ruled that generic drug manufacturers could not be sued under state law for failure to warn patients regarding a drug’s side effects provided that their product label is identical to the reference listed drug’s label. The decision was based upon federal law requiring generic labels to match RLD labels pre-empting state law requiring strengthening of labels as manufacturers become aware of new risks.

 
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