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In Mesh Case, Court Rejects Argument that Comment K Only Bars Claims Involving "Properly Prepared" Devices and Dismisses Strict Liability Claims

June 13, 2016

In a case involving polypropylene mesh, a Pennsylvania federal district court held strict liability claims involving medical devices are barred by Comment k to the Restatement (Second) of Torts § 402A. In the case, Carson v. Atrium Medical Corporation, plaintiff asserted strict liability and negligence claims arising from the use of polypropylene mesh to repair a hernia. The district court granted the defendant manufacturer’s Rule 12(b)(6) motion to dismiss, dismissing plaintiff’s strict liability claims with prejudice.

In broad terms, Comment k bars strict liability claims against drugs that are properly prepared and accompanied by proper directions and a warning. Even though the Pennsylvania Supreme Court has not addressed whether Comment k applies to devices as well as drugs, the Carson court made quick work of the dispositive issue, observing that both the lower appellate courts of Pennsylvania and several federal district courts applying Pennsylvania law had extended Comment k to medical devices.

The Carson court also dispatched swiftly plaintiff’s argument that Comment k could only apply to devices that are properly prepared and accompanied by proper directions and warnings, observing that the Pennsylvania Supreme Court had rejected that caveat in prescription drug cases. “Thus, Plaintiff’s argument that exceptions be made is unpersuasive, and the Court will apply Comment k, without exceptions, to medical devices.” Carson, 2016 WL 3181414, *3 (W.D. Pa., June 8, 2016).

Plaintiff’s negligence claim survived the motion to dismiss. However, the district court’s order reflects the claim being dismissed without prejudice, suggesting that Plaintiff will be taking an appeal to the U.S. Court of Appeals for the Third Circuit.

The full Carson v. Atrium Medical Corporation opinion can be found here.