A Pennsylvania federal court has again asked that the state’s Supreme Court clarify whether, and to what extent, medical device manufacturers are immune from strict liability claims by virtue of the “unavoidably unsafe products” exemption recognized in Restatement (Second) of Torts Sec. 402A cmt. k (“Comment k”)—only this time with a direct certification.
On Thursday, the Third Circuit Court of Appeals certified that question to the Pennsylvania Supreme Court, along with a question about which negligent design defect theory—or theories—a Pennsylvania plaintiff may assert against a medical device manufacturer. Pet. for Certification of Questions of State Law, ECF No. 50, Ebert v. C.R. Bard, Inc., et al., No. 20-2139 (3d Cir. June 24, 2021) (“Ebert Pet.”). Last spring, Judge Pappert of the Eastern District of Pennsylvania dismissed Ms. Ebert’s strict liability claim, finding her IVC filter “an ‘unavoidably unsafe product’” under Hahn v. Richter, 673 A.3d 888 (Pa. 1996), and she appealed that order granting summary judgment to the Third Circuit.
[Notice/Disclaimer — Faegre Drinker filed an amicus brief in this case supporting the position of the Defendants/Appellees.]
Pennsylvania has long recognized Comment k immunity for prescription medications grounded in public policy and common law, but immunity has been inconsistently applied to prescription medical devices, particularly in federal decisions subsequent to the watershed products liability opinion Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014). Tincher did not involve a prescription medicine or device, but its discussion is significant for adopting a Pennsylvania-specific interpretation of the Restatement (Second) of Torts. Tincher rejected categorical exemptions from strict liability as inappropriate for courts to make, but it also acknowledged the strict liability immunity for prescription drugs derived from common law.
In 2019, Judge Robreno of the Eastern District of Pennsylvania found that Pennsylvania’s strict liability immunity applies equally to prescription drugs and medical devices. Rosenberg v. C.R. Bard, Inc., 387 F. Supp. 3d 572, 580–81. (E.D. Pa. 2019) (“[N]othing in Tincher reopens the door to strict liability claims for prescription drugs or prescription medical devices, a door Hahn had firmly closed.”). However, Judge Robreno acknowledged that the Pennsylvania Supreme Court had not explicitly applied Comment k to foreclose strict liability–manufacturing defect claims, and requested that the Third Circuit certify the question. Our analysis of that opinion is available here. Three days later, plaintiff withdrew her strict liability claims, sidestepping any potential certified review. Similar strict liability issues were raised in several cases appealed from the Philadelphia Court of Common Pleas, but those were not addressed on the merits by the Pennsylvania Supreme Court.
The underlying Ebert opinion stands apart from either line of strict liability decisions because it rejected both categorical immunity for medical devices and the clear inapplicability of Comment k. Instead, Judge Pappert predicted that under Tincher, Pennsylvania law would recognize a case-by-case immunity for implantable medical devices, because “Courts . . . are neither positioned, nor resourced, to make the kind of policy judgments required” to recognize categorical exemptions. Ebert, 459 F. Supp. 3d 637, 652 (E.D. Pa. 2020). Left unaddressed is exactly which “individual characteristics of the medical device at issue” would resolve the question, although the Court applied Comment k immunity based in part on record evidence that “it is impossible to design an implantable medical device with zero risk of failure.”
As the Third Circuit noted, “if this third approach is the proper approach,” the analysis is further complicated by the question of whether the court ought focus on the “general type of device at issue” or the “specific model.”
Negligent Design Defect
The Third Circuit also asked the Pennsylvania Supreme Court to resolve whether plaintiffs claiming negligent design defect must establish that the medical device was “too harmful to be used by anyone,” as articulated in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014), or whether plaintiffs may establish negligent design defect by another theory, such as “alternative safer design.” As the Court restated: “[D]oes Lance set the floor or the ceiling for negligent design claims against prescription medical devices?”
In Ebert, the District Court had concluded “[t]here is no record evidence that Bard placed the G2 filter into the market ‘with actual or constructive knowledge that the [device was] too harmful to be used by anyone.’” Judge Pappert disagreed with Ms. Ebert that Lance would permit her to establish a negligent design defect based on the argument Bard could have designed the IVC filter in a different fashion, noting “the alternative design approach is not an easy fit measured against conventional design theory . . . on account of speculativeness concerning whether FDA approval could ever be had for a new design.” However, the Third Circuit noted three decisions from the Eastern District of Pennsylvania which “read Lance as leaving open additional theories of liability.”
We continue to await the Pennsylvania Supreme Court’s answer to plaintiffs’ knock on that door—or ceiling, or floor.