Here is one to watch. The Pennsylvania Supreme Court has agreed to hear a case on recommendation from the Third Circuit dealing with when state law bars negligent design and strict liability claims related to medical devices. Melissa Ebert v. C.R. Bard Inc., No. 26 EAP 2021 (Pa.).
A little background. Ever since the Tincher case updated Pennsylvania’s product liability doctrine (erasing the old Azzarello doctrine), Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), plaintiffs have attempted to muddy the prescription product waters given the Supreme Court’s decision to leave the precise contours of its rulings to the lower courts. For example, the federal courts here are split over whether the “unavoidably unsafe product” exception of comment k to Section 402(A) to the Restatement (Second) of Torts, which expressly bars strict liability design defect claims against manufacturers of prescription drugs, also bars those claims against manufacturers of prescription medical devices. This despite the fact there is no principled distinction between prescription drugs and prescription medical devices for purposes of comment k analysis.
The district court in this matter got the comment k question wrong, but did recognize that in a negligent design claim against a prescription device, another contested area, the relevant duty of care is narrow, A manufacturer breaches the duty only if it introduces a product too dangerous to be used by any patients. Ebert v. C.R. Bard, 2020 WL 2332060 (E.D. Pa. May 11, 2020). The Third Circuit certified both questions. Petition for Certification of Questions of State Law, Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *6 (3d Cir. June 24, 2021).
The Court will consider the following issues: (1) Under Pennsylvania law, must a plaintiff bringing a negligent design claim against a prescription medical device manufacturer prove that the device was too harmful to be used by anyone, or may the plaintiff also prevail on other theories of liability where appropriate? (2) Under Pennsylvania law, are prescription implantable medical devices categorically subject to strict liability, categorically immune from strict liability, or immune from strict liability on a case-by-case basis? If they are immune on a case-by-case basis, what test should a court apply to determine whether a particular device is immune?