Gustavsen v. Alcon Laboratories, Inc.
Court of Appeals for the First Circuit
1Opinion of the Court
KAYATTA, Circuit Judge.
*4 Our disposition of the merits of this appeal turns on a single question: Can manufacturers of prescription eye drops change the medication's bottle so as to alter the amount of medication dispensed into the eye without first getting the FDA's approval? Finding that federal law requires prior approval for such a change, we hold that state law claims challenging the manufacturers' refusal to make this change are preempted. Our reasoning follows.
I
Because this appeal comes to us following the district court's grant of a motion to dismiss, we draw the facts from the…
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