Subject: Pennsylvania

Does Pennsylvania Recognize Strict Liability Claims Against Medical Device Manufacturers? A Pennsylvania federal court calls the question.

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For at least two decades, Pennsylvania law has recognized an exemption from strict liability for prescription drug manufacturers based on the state Supreme Court’s interpretation of the Restatement (Second) of Torts Sec. 402A cmt. k.  Comment k carves out an exception to traditional strict product liability claims for “unavoidably unsafe products,” or those which bear inherent risks—such as medicines which must be prescribed by a doctor.  A less settled question is whether that exemption extends to manufacturers of prescription medical devices, specifically regarding manufacturing defect claims.  On June 25, 2019, Judge Robreno of the U.S.D.C. Eastern District of Pennsylvania asked the Third Circuit to answer it.

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