Pa. Federal Judge Refuses to Extend Comment k Immunity to Pelvic Mesh Device

PITTSBURGH — A Pennsylvania federal judge has denied Ethicon summary judgment on strict liability claims in a pelvic mesh action, ruling that the immunity afforded under comment k to Section 402A of the Restatement (Second) Torts does not extend to the device because it is not “unavoidably unsafe.”

In an Oct. 5 order, Chief Judge Mark R. Hornak of the U.S. District Court for the Western District of Pennsylvania also ruled that the plaintiff sufficiently alleged that her injuries were caused by the device’s defective design and inadequate warnings.

Randi Cohen underwent implantation of Ethicon’s Gynemesh pelvic mesh device on …