Infuse Claims Asserted Against Hospital Preempted, Barred, Ky. Appellate Court Rules

FRANKFORT, Ky. — Product liability claims asserted against a healthcare provider in an off-label Medtronic Infuse action are federally preempted, a Kentucky appellate court has held, because they seek to impose state law standards as to how a device is used, which the Medical Device Amendments does not address.

In a Jan. 13 opinion, the Kentucky Court of Appeals further held that the product liability negligence claims are defeated by the state’s “middleman statute,” which shields distributors from liability for products that are sold in their original manufactured condition or package.

However, the appellate court reinstated the plaintiffs’ medical negligence …