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High Court Won’t Hear InFuse Off-Label Preemption Case

The case would have tested whether manufacturers could be held liable if an FDA-approved device injured a patient when the product was employed for an off-label, unapproved use. The Oklahoma Federal Court and the 10th Circuit Court of Appeals had both previously ruled in industry’s favor.

The Supreme Court won’t rule this term on whether medical device manufacturers are liable for injuries caused by off-label device use.

The justices announced Jan.11 that they would not hear an Oklahoma woman’s appeal of a lower court decision in favor...

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