Courtney A. Stevens, Esq. | Senior Attorney, Medmarc Loss Control
Yesterday I spoke on the products liability implications of 3D printing in the life sciences industry at the Inside 3D Printing Conference in New York, New York. In preparing for my presentation and attending the conference, several fundamental challenges for products liability law in adapting to this transformative technology became apparent to me, and I provide some of my observations below.
Products liability is an area of tort law that developed in part as a way of incentivizing product manufacturers to ensure the safety of their products by imposing legal liability and financial responsibility on them if their products harm users. In its faltering application to 3D printer “users,” this rationale offers one example of how traditional products liability law doesn’t seem to quite ‘fit’ the new designer-manufacturer-user construction that 3D printing brings about.
At the heart of the transformative effects of 3D printing is the shift in and/or muddling of the roles in a traditional products liability context. Products liability law works to apportion liability among the various parties and various roles involved in the development and sale of a product—the designer, the manufacturer, and the distributor, for harm incurred by the consumer and/or end-user.
In 3D printing, however, the roles of designer, manufacturer, and distributor are no longer clearly defined or delineated by their actions. Who, for example, is the manufacturer in the context of a 3D-printed bone implant? Is it the imaging device that transmitted the images of the patient’s anatomy to the software of the 3D printer? Is it the software that translated that image into a CAD file? Is it the manufacturer of the 3D printer? Is it the healthcare worker at the point of care that executes the printing? And in imposing liability on any of these parties, are products liability’s goals of incentivizing safety in the parties that can exercise control really served? When commercial products are developed not en masse but on a one-off scale, does the imposition of products liability still function as intended?
Somewhat curiously given the growth in utilization of the technology over the last few years, we are still waiting for the first products liability suit involving a 3D printed product. Until then, we can only speculate as to the law’s prospective adaptation to the paradigm shift 3D printing represents.