MASSACHUSETTS -

First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In Studies Already Submitted To FDA And Hence Were Not “Newly Acquired Information” Permitting Defendant To Change Its FDA Approved Labeling, And There Was “Clear Evidence” FDA Would Have Rejected Labeling Change Because It Later Rejected Similar Labeling With Awareness Of The Cited Studies.