Predicting what the PA Supreme Court would do, the Eastern District Court finds strict liability claim against prescription medical device manufacturer is barred.

The plaintiff's doctor implanted in her a Bard G2 inferior vena cava filter—a prescription medical device—to prevent pulmonary embolism. One of the filter struts eventually fractured and migrated to the plaintiff’s pulmonary artery. Both the filter and fractured strut were later removed without complication and without any physical damage to the plaintiff (other than the procedure itself). The plaintiff filed suit against the manufacturer of the medical device, alleging claims of negligence, breach of express warranty, negligent misrepresentation and strict liability. The defendant filed a motion for summary judgment on all claims, which the court granted in its entirety. With respect to the product liability claim, the Pennsylvania Supreme Court has yet to say whether Pennsylvania law recognizes a strict liability claim against prescription medical device manufacturers. As such, the Eastern District of Pennsylvania makes a prediction as to whether the Pennsylvania Supreme Court would recognize the plaintiff's claim against Bard for its G2 filter. From a review of the available sources, the Eastern District Court predicts that the Pennsylvania Supreme Court would bar a strict liability cause of action against the defendant for its G2 filter, although the court states that this prediction is "limited to the facts of this case and the individual characteristics of the IVC filters." This decision is based on the Pennsylvania Supreme Court's adoption of comment k of the Restatement (Second) of Torts § 402A to bar strict liability claims against manufacturers of prescription drugs. However, the court goes through recent holdings by the Supreme Court (Tincher v. Omega Flex, 104 A.3d 328 Pa. (2014) and Lance v. Wyeth, 85 A.3d 434 (Pa. 2014)), which leads the court "to predict that the Pennsylvania Supreme Court would not categorically extend prior case law and comment k to all prescription medical device manufacturers. Rather, the “court predicts that Pennsylvania's highest court would instead analyze comment k's applicability to prescript medical devices on a case-by-case basis, determined largely by each case’s developed factual record and the individual characteristics of the medical device at issue," with a focus on whether the product is an unavoidably unsafe product in which comment k would apply, like the Bard G2 filter.

_{Case Law Alerts, 3rd Quarter, July 2020 is prepared by Marshall Dennehey Warner Coleman & Goggin to provide information on recent developments of interest to our readers. This publication is not intended to provide legal advice for a specific situation or to create an attorney-client relationship. Copyright © 2020 Marshall Dennehey Warner Coleman & Goggin, all rights reserved. This article may not be reprinted without the express written permission of our firm.}