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.

In Rosenberg v. C.R. Bard, Inc., — F. Supp. 3d —, 2019 WL 2596358 (E.D. Pa. 2019), plaintiff suffered from stress urinary incontinence and was implanted with a prescription pelvic mesh material.  She claimed the pelvic mesh caused personal injuries and thereafter filed a complaint alleging strict liability claims for design defects, manufacturing defects, and failure to warn defects, as well as defendants’ negligence.  The court granted defendants’ motion to dismiss the strict liability claims with prejudice.  (Plaintiff’s negligence claims were dismissed without prejudice with leave to amend.)  It also certified to the Third Circuit “the question of whether Pennsylvania recognizes a strict liability claim for a manufacturing defect of a prescription medical device.”  In the ruling, Judge Robreno predicted that comment k’s prohibition on prescription product strict liability claims would prove absolute.

Pennsylvania law recognizes three types of strict products liability claims: design defect claims, failure to warn claims, and manufacturing defect claims.  As discussed by Judge Robreno, Pennsylvania law directly addresses—and precludes—strict liability design defect and failure to warn claims for prescription drugs and devices.  While there has been significant litigation in Pennsylvania state courts over whether strict liability design defect and failure to warn claims can be leveled against prescription medical device manufacturers, Judge Robreno treated this as a resolved issue, citing Creazzo v. Medtronic, Inc., 903 A.2d 24 (Pa. Super. Ct. 2006) and Pa. Suggested Standard Jury Instructions Sec. 23.00 (May 2015).  However, the Pennsylvania Supreme Court has not specifically addressed strict liability manufacturing defect claims for prescription medical devices, and the Pennsylvania federal district courts have produced a split within the Circuit.  Judge Robreno referenced nine cases permitting a strict liability manufacturing defect claim and five cases dismissing the same.

The narrow issue of manufacturing defect claims brings the question to the Third Circuit, but the Rosenberg opinion appears mindful of the significant implications the answer could have.  Judge Robreno referenced the impending “closure of the pelvic mesh MDL,” one of the largest MDL programs ever commenced, and suggested in a footnote that the Third Circuit pass the question directly to the Pennsylvania Supreme Court as the issue “continues to evade review” in that forum.

In dismissing plaintiff’s strict liability claims, Judge Robreno opined that “for the purposes of comment k, no meaningful distinction can be drawn between prescription drugs and prescription medical devices,” and predicted this reasoning would be extended again.  He also commented that plaintiff’s reliance on the seminal case Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), almost five years old, is unavailing.  “[N]othing in Tincher reopens the door to strict liability claims for prescription drugs or prescription medical devices, a door Hahn had firmly closed.”  We will wait to see how the Third Circuit—or the Pennsylvania Supreme Court—answers plaintiffs’ persistent knock.