STORY FROM: Drugs & Medical Devices

Warning Claims Against NDA Holder of Invokana Not Preempted, Ga. Federal Judge Rules

ROME, Ga. — Strict liability claims asserted against Janssen Pharmaceuticals accusing it of failing to strengthen Invokana’s warning regarding the risk of diabetic ketoacidosis are not preempted, a Georgia federal judge has ruled, explaining that federal law does not bar the current holder of a new drug application from altering a drug’s label.

However, in the July 11 order, Judge Harold L. Murphy of the U.S. District Court for the Northern District of Georgia held that warning claims asserted against non-NDA holders are preempted because federal law does not empower them to change a drug’s label.

Paula Brazil sued Janssen ...

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