Strict Liability and 3D-Printed Medical Devices

4 Pages Posted: 3 Dec 2015 Last revised: 10 Jul 2022

See all articles by Eric Lindenfeld

Eric Lindenfeld

University of Minnesota - Minneapolis

Jasper L. Tran

Harvard Business School

Date Written: November 17, 2015


Despite the strong promise that 3D printing holds for the future healthcare, there are critical concerns, and deep unknowns regarding the framework for potential tort liability. And while there has been only a single product liability lawsuit involving a 3D-printed product to date, there are tremendous concerns that 3D printing will present significant safety concerns for the first wave of consumers. While an application of traditional product liability principles may seem to be straightforward, those familiar with the framework realize that an application of those principles to 3D printing is complicated and unique. The question then exists – who is the manufacturer of a product created by a 3D printer as contemplated by the Restatement? Could a hospital be considered a manufacturer of a defective 3D-printed product or as “engaging in the business” of selling the product?

3D printing, in effect, will serve as one of the first technological advances to disrupt the product liability regime first envisioned, and eventually instituted by Justice Traynor. To avoid such an undesirable result, it is imperative that courts make a concerted effort to redefine the boundaries of product liability law to account for new technologies and to make room for liability to those supply chains which do not engage in traditional manufacturing. More specifically, the most realistic approach to the problem would be for courts to uniformly hold software designers responsible for the defects in 3D-printed products. Hospitals, or 3D printing manufacturers, should not be held strictly liable for any defect in the medical product.

Keywords: 3D printing, medical devices, strict liability, torts

JEL Classification: K00, K10, K19, K20, K29, K30, K39, K40, K41, K49

Suggested Citation

Lindenfeld, Eric and Tran, Jasper, Strict Liability and 3D-Printed Medical Devices (November 17, 2015). Yale Journal of Law and Technology The Record, Vol. 17, 2015, Available at SSRN:

Eric Lindenfeld

University of Minnesota - Minneapolis ( email )

110 Wulling Hall, 86 Pleasant St, S.E.
308 Harvard Street SE
Minneapolis, MN 55455
United States

Jasper Tran (Contact Author)

Harvard Business School ( email )

Soldiers Field
Boston, MA 02163
United States

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