The Third Circuit Seeks Answer From Pennsylvania Supreme Court Regarding Medical Device Strict Liability

On June 24, 2021, the Third Circuit once again sought clarification from the Supreme Court of Pennsylvania regarding whether and till what extent medical device manufacturers enjoy immunity from strict liability claims by virtue of the “unavoidably unsafe products” exemption stated in Restatement (Second) of Torts, Sec. 402A cmt.k (“Comment K”). Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”)

The Court certified that question to the Pennsylvania Supreme Court along with a question regarding which negligent design defect theory should be put forth by a plaintiff against a medical device manufacturer. Last year, when the case was heard by Judge Pappert of the Eastern District of Pennsylvania, plaintiff’s strict liability claim and held that her IVC filter “an unavoidably unsafe product”. Thereby, an appeal was filed before the Third Circuit.

The State of Pennsylvania has recognized the Comment k immunity since a long time for prescription medications grounded in public policy and common law. However, the immunity has been inconsistently applied to prescribed medical devices, especially in decisions delivered by federal courts, subsequent to the watershed products liability opinion in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014). Although the Tincher decision does not involve a prescribed medicine or device, however, the decision is significant for adopting a Pennsylvania-specific interpretation of the Restatement (Second) of Torts. The decision rejected categorical exemptions from strict liability and acknowledged the strict liability immunity in cases of prescription drugs derived from common law. However, in 2019, Judge Robreno of the Eastern District of Pennsylvania held that the state’s strict liability immunity applied equally to prescription drugs and medical devices. Rosenberg v. C.R. Bard, Inc., 387 F. Supp. 3d 572, 580–81. (E.D. Pa. 2019).  In addition, Judge Robreno acknowledged that the Pennsylvania Supreme Court has not explicitly applied the Comment K to foreclose strict liability in manufacturing defect claims and requested Third Circuit to certify the question.

Opinion of Judge Pappert in the present case stands different from both the aforesaid cases as the Judge rejected both, categorical immunity for medical devices and the clear inapplicability of Comment k. Instead, Judge Pappert that while applying the Tincher ruling, the Pennsylvania law would recognize a case specific immunity for implantable medical devices and held that “Courts . . . are neither positioned, nor resourced, to make the kind of policy judgments required” to recognize categorical exemptions.” Ebert v. C.R. Bard Inc., 459 F. Supp. 3d 637, 652 (E.D. Pa. 2020). Upon appeal, the Third Circuit stated that “if this third approach is the proper approach,” the analysis is further complicated by the question of whether the court ought focus on the “general type of device at issue” or the “specific model.”

The Third Circuit also asked the State’s Supreme Court to determine whether plaintiffs claiming negligent design defect have to establish that the medical device was “too harmful to be used by anyone”, or whether the plaintiffs can establish the claim of negligent design defect by any another theory such as “alternative safer design”.

As evident, there has been a lot of air of confusion with regards to application of strict liability in matters involving prescription medicines and/or devices and the Court was correct in putting forth the issue in question before the Pennsylvania Supreme Court.



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