Pennsylvania products liability law recognizes strict liability and negligence claims for design defect, manufacturing defect and failure to warn. However, Comment k to Section 402A of the Restatement (Second) of Torts precludes all strict liability claims arising from injuries caused by certain categories of products, including prescription pharmaceuticals and medical devices. This widely adopted rule leaves drug and device manufacturers subject to negligence claims only. The balance struck by Comment k ensures the availability of critical, life-saving therapies by eliminating liability for unavoidable harms.
Pennsylvania’s Unqualified Application of Comment k
Establishing its premise, Comment k begins by acknowledging that certain products “are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs.” Comment k then instructs that, “the seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given … is not to be held to strict liability.” The rationale for applying Comment k to bar non-negligence claims is that certain products are important and desirable, even though they cannot be made entirely safe.