Comment k Bars Strict Liability Claims Against Medical Device Maker, Pa. Federal Judge Rules

PHILADELPHIA — Strict liability claims asserted against Synthes in connection with its N-Hance spinal fixation rod system are barred by Comment k to the Restatement (second) of Torts, a Pennsylvania federal judge has ruled, reasoning that the device is “unavoidably unsafe.”

On July 15, Judge Jeffrey Schmehl of the U.S. District Court for the Eastern District of Pennsylvania held that although the state high court has not yet addressed whether comment k extends to medical devices, the Pennsylvania Superior Court has held that there is “no reason why the same rationale applicable to prescription drugs may not be applied to …