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# Pennsylvania Courts Assess Medical Device Strict Liability
- URL: https://www.fdaweb.com/pennsylvania-courts-assess-medical-device-strict-liability/
- Published: 2019-07-11T12:00:00.000Z
- Updated: 2026-09-15T01:37:11.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144516

A Pennsylvania federal court has asked the 3rd Circuit Court of Appeals to answer whether the state recognizes a strict liability claim for a manufacturing defect of a prescription medical device. A Washington Legal Foundation (WLF) *Legal Pulse* online [post](https://www.wlf.org/2019/07/09/wlf-legal-pulse/inherently-risky-but-socially-beneficial-court-in-pa-to-rule-on-strict-liability-for-medical-devices/?ref=fdaweb.com) says the Pennsylvania case is similar to one pending in the Utah Supreme Court for which WLF submitted an *amicus* brief urging the court to apply the “unavoidably unsafe” exception to strict product liability in the case of prescription medical devices.

The post says that the Pennsylvania Superior and Supreme courts have barred strict liability claims in prescription drug cases for design defect and failure-to-warn claims based on a determination that prescription drugs are “inherently dangerous products which benefit society.”

The judge in the case going to the 3rd Circuit predicted Pennsylvania would extend its strict liability position to prescription medical devices. Notably, the post says, Pennsylvania has not specifically prohibited strict liability claims for manufacturing defects in the prescription product context. So the federal court needed to predict whether state law would extend to bar such claims. The court noted that a split has developed among the lower Pennsylvania courts on applicability of strict liability to manufacturing defect claims. The judge said that based on case law and the lack of a meaningful distinction between the legal treatment of prescription drugs and prescription medical devices, the state Supreme Court likely would not recognize a strict liability claims for a manufacturing defect of a prescription medical device.

The post says it is likely the 3rd Circuit will certify the question to the Pennsylvania Supreme Court, rather than guessing what that court would hold.