855 Products Liability – Unavoidably Unsafe (2024)

In Douglas v. Atrium Medical Corp., No. 3:23-CV-0747, 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024), a Pennsylvania District Judge dismissed strict liability claims from the lawsuit alleging injuries caused by Atrium Medical’s ProLoop and ProLite hernia mesh, ruling that they fall within the exemption in comment k to Section 402A of the Restatement (Second) of Torts for “unavoidably unsafe” products. In her order, Judge Julia K. Munley of the U.S. District Court for the Middle District of Pennsylvania agreed with a magistrate judge who predicted that the state’s high court would follow decisions that extended comment k’s exemption to medical devices.

The district court rejected the plaintiffs’ objection on strict liability and adopted the magistrate’s R&R on this issue without much fanfare:  “The court agrees, and dismissal of Counts I and II is appropriate.”  Because other counts remained, the court also considered plaintiffs’ request that it certify an interlocutory appeal to the Third Circuit to present the issue of strict liability for prescription implantable medical devices under Pennsylvania law.  Part of the test for certifying an interlocutory appeal under 28 U.S.C. § 1292(b) is whether there is “substantial ground for difference of opinion.”  The Douglas court found that there was not:

Here, the court finds that no substantial ground for difference of opinion as to whether plaintiffs’ strict liability claims should be dismissed.  As explained above, the appellate courts of Pennsylvania have ruled that the law supports dismissal.  Additionally, district courts within this judicial district have also ruled that implanted medical devices are exempted from strict liability.

Id. at *4. This all means that, despite some adverse decisions from federal courts in Pennsylvania, including in the same district as Douglas, the latest word on whether Pennsylvania law supports strict liability claims against an implantable medical device is that there is no substantial ground to conclude that it does. Judge Munley also dismissed the breach of express warranty claim.