By Shaila Rahman Diwan, Julia E. Romano, and Lisa M. Dwyer, Partners with King & Spalding LLP in the firm’s New York, NY, Los Angeles, CA, and Washington DC offices, respectively.

A federal district court in the Eastern District of Pennsylvania recently issued a decision that will help foster innovation in the medical device industry, and ultimately provide patients with greater access to important medical products.  Keen v C.R. Bard, Inc., No. CV 13-5361, 2020 WL 4873634, at *8 (E.D. Pa. Aug. 19, 2020).  In Keen, the court found that comment k to the Restatement Second, Torts section 402A applies to medical devices, adding to the body of case law in Pennsylvania and across the country which has held that medical devices are exempt from strict products liability. 

Comment k to the Restatement Second, Torts section 402A exempts manufacturers of certain “unavoidably unsafe” products, including prescription drugs, from strict liability because the potential benefit presented by such products outweighs their known, appreciable risks.  The comment provides critical protection for manufacturers of prescription drugs and other important medical products.  Without it, medical product manufacturers may be hesitant to invest in innovative therapies that advance patient care.  Unfortunately the ambiguity of the text of comment k—which exempts “drugs, vaccines, and the like, many of whichcannot legally be sold except to physicians, or under the prescription of a physician” (emphasis added)—has led to an inconsistent patchwork of decisions in Pennsylvania and other states regarding whether, and to what extent, comment k also applies to medical devices.  The uncertainty created by this patchwork has long threatened to stymie device innovation and patient access.  Thus, the decision in Keen pushes the body of case law in the right direction.

In Keen, the plaintiff was involved in a serious motorcycle accident resulting in multiple skull fractures and traumatic brain injury.  Keen, at *2.  Following the accident, Mr. Keen’s physician placed a temporary G2X inferior vena cava (IVC) filter—manufactured by the Bard defendants and cleared by FDA through the 510(k) process—in Mr. Keen’s vena cava (the largest vein leading to the heart) as a precautionary measure to prevent a pulmonary embolism.  Id.  Three months later, when another physician attempted to retrieve the G2X filter implanted in Mr. Keen, it was discovered that the filter had fractured and tilted.  Id.  Approximately one month later, another physician performed a second procedure to retrieve the filter.  Id.  The filter and most of the fractured components were successfully removed from Mr. Keen’s vein.

Mr. Keen thereafter filed a products liability lawsuit against the Bard defendants alleging the G2X filter was defective and caused him injury.  Id.  Specifically, Mr. Keen brought strict liability and negligence claims alleging design defect, manufacturing defect, failure to warn, a negligent misrepresentation claim, and an implied warranty of merchantability claim.  Id. at *5.  Mr. Keen also sought punitive damages.  Id.  The Bard defendants moved for summary judgment on all of Mr. Keen’s claims.  Id.

This case presented the U.S. District Court for the Eastern District of Pennsylvania with a question not yet definitively answered by the Pennsylvania Supreme Court, and answered with mixed results by other district courts: Does comment k’s “unavoidably unsafe” exemption apply to prescription medical devices, thereby barring strict liability claims in such cases?  If so, are all theories of strict liability—design defect, manufacturing defect, and failure to warn—barred?

The Keen court recognized that the Pennsylvania Supreme Court “has long interpreted comment k to bar strict liability claims in the context of prescription drugs” but “has yet to specifically address comment k’s application to prescription medical devices.”  Id. at *6 (emphases in original).  Absent a controlling decision by the Pennsylvania Supreme Court, the district court was tasked with predicting how Pennsylvania’s highest court would decide the issue.  Id.  Ultimately, the court predicted that the Pennsylvania Supreme Court “would apply comment k to all of Mr. Keen’s strict liability claims,” and therefore granted summary judgment in favor of the Bard defendants on those claims.

In reaching its decision, the Keen court cited a Superior Court of Pennsylvania case wherein that court held plaintiffs could not pursue a strict liability claim against the manufacturer of an implantable neurological electrical stimulation device.  Id. (citing Creazzo v. Medtronic, Inc., 903 A.2d, 24, 31 (Pa. Super. Ct. 2006)).  The court also noted that “many district courts applying Pennsylvania law have similarly predicted that the Pennsylvania Supreme Court would likely extend its bar of strict liability of prescription drug claims to claims involving prescription medical devices.”  Id. at *6 (citing a number of district court decisions which found that strict liability claims were barred in medical device cases, such as those involving medical mesh, artificial hips and pain pump catheters).

The Keen decision is also noteworthy because it addresses which theories of strict liability are barred by comment k.  Mr. Keen argued that if comment k applied, it would only apply to his design defect and failure-to-warn theories of liability, not to his manufacturing defect claim.  Notably, the court found it unlikely that the Pennsylvania Supreme Court “would deviate from its otherwise uniform application of comment k in order to permit strict liability claims based on manufacturing defect theory.”  Id. at *7.  Thus, the court not only held that comment k applies to prescription medical devices but that its bar applies across the board to all theories of strict liability—design defect, failure to warn, and manufacturing defect.1

With this decision, the Eastern District of Pennsylvania joins multiple other courts across the country that have come to the same logical and practical conclusion in finding comment k’s “unavoidably unsafe” exemption applies to both prescription drugs and medical devices.  Medical devices, like prescription drugs: (1) are subject to intense scrutiny and elaborate regulatory oversight by FDA; (2) provide tremendous, often life-saving, health benefits to many individuals; and (3) are subject to the same policy considerations that unpredictable liability will necessarily chill innovation and development, or otherwise lead to price increases, and, therefore, limit or reduce patient access to important health products.  Accordingly, whether interpreting comment k or analyzing the policies affected, there is simply no reason to distinguish prescription drugs and medical devices.


  1. Notably, the court also granted Bard summary judgment on plaintiff’s implied warranty of merchantability claim.  The court noted that multiple courts “have recognized that the theories of strict liability and breach of implied warranty of merchantability ‘are parallel theories of recovery,’ one in contract and the other in tort.’”  Id. at *14 (citation omitted).  As such, the court granted summary judgment in favor of Bard on plaintiff’s implied warranty of merchantability claim for essentially the same reasons that it granted summary judgment on the strict liability claims.