Pre-, Post-Approval Claims Ruled Preempted in Aimovig Migraine Drug Action

BOSTON — A Massachusetts federal judge has dismissed a lawsuit accusing Amgen Inc. of failing to properly test its migraine drug Aimovig on seizure-prone individuals before it was approved, ruling the claim is preempted because the FDA was fully aware of the exclusion criteria used in the drug’s clinical trials.

In a Feb. 13 order, Judge Julia Kobick of the U.S. District Court for the District of Massachusetts further ruled that the plaintiff’s post-approval claim is preempted because she did not present “newly acquired evidence” that would have warranted a label change via the Changes Being Effected regulation.

Plaintiff’s son …