Does Pennsylvania Permit Manufacturing Defect Claims Involving Medical Devices?

I am writing to report about a recent dismissal of a manufacturing defect claim made against a medical device manufacturer in the USDC for the Eastern District of Pennsylvania. This decision is favorable to our clients that are involved in defending medical devices. We believe this case may dissuade plaintiffs from filing cases against medical device manufacturers in Pennsylvania in the future, at least in federal court.

It has been a long-standing principle in Pennsylvania that the doctrine of strict products liability does not apply in cases involving prescription drugs. This principle was recently affirmed by the Supreme Court of Pennsylvania in the case of Lance v. Wyeth, 15 A3d 434 (PA 2014), which was decided earlier this year. As was stated in Lance, for policy reasons strict products liability claims are barred against manufacturers of prescription drugs under Pennsylvania law. However, the Supreme Court of Pennsylvania has yet to rule whether this ban also applied to prescription medical devices. Before the decision in Lance was made earlier this year, the federal courts in Pennsylvania had ruled that manufacturing defect claims were permissible in cases involving prescription medical devices.

However, more recently a federal court judge for the Eastern District of Pennsylvania in the case of Terrell v. C.R. Bard decided that the ban against strict products liability claims in cases involving prescription drugs also includes prescription medical devices. The Terrell case involves a mesh implanted in the plaintiff’s abdomen that deformed and contracted, causing her to incur various internal injuries. The plaintiff sued Marlex, the manufacturer of the mesh, asserting manufacturing defect and breach of warranty claims, among others, in her lawsuit. The court dismissed the breach of warranty and manufacturing defect claims filed against Marlex following the decision set forth by the Pennsylvania Supreme Court in Lance.

As a result of the recent decision in Terrell, rejecting the notion that manufacturing defect claims are permissible in cases involving prescription medical devices, a clear split in authority exists between the federal district courts of Pennsylvania on the issue. It will be interesting to see whether the appellate courts address this split in authority anytime soon. We believe the reasoning set forth by the court in Terrell is logical, and hopefully it will be the position that is ultimately embraced by the Supreme Court in Pennsylvania in the future. For now, the Terrell decision serves as persuasive authority to support the notion that manufacturing defect claims are not permitted under Pennsylvania law.

We welcome our reader’s comments and questions.

This blog post was published originally on September 17, 2014.