3D printing has the potential to disrupt and transform not only how and where objects are made, but all aspects of the law, including products liability. In their recent article, 3D Printing: What Could Happen to Products Liability When Users (And Everyone Else in Between) Become Manufacturers (18 Minn. J.L. Sci. & Tech. 145), James Beck and Matthew Jacobson explore the legal implications 3D printing may have on product liability common-law and how courts, legislatures, and regulatory agencies may act in the wake of this novel technology. The first part of this comprehensive guide covers what is 3D printing and how this new technology works, an overview of traditional tort liability concepts, and the gray area that forms when the two meet. The second part of the article focuses on 3D printing’s impact on medical devices and health care and the product liability considerations that are specific to these highly technical and potentially life-saving products.
Given that 3D printing appears to be the next greatest chapter in the industrial revolution, with the technology often moving more rapidly than the law, this article is significant in that it comprehensively analyzes the current state of products liability law and the legal issues affecting this body of law arising from the 3D printing of products.
As the article explains, 3D printing is already starting to revolutionize different industries, including automotive, aerospace, and healthcare. Individuals can already “print” products from a store (online or brick-and mortar) and their own homes (assuming they have a 3D printer and the necessary software and supplies). In the future, airplane parts may be able to be printed from airports, car parts at a mechanic’s shop, and medical devices at a hospital or doctor’s office. As the technology develops, the question becomes will the law also develop, especially as people get injured by these 3D printed products and the processes in by which they are printed.
Products liability is a relatively new area of the common law—although not as new as 3D printing—beginning its development in the 1960s, when manufacturing transitioned from local artisans and workshops to assembly-line processes. Now that 3D printing may once again change the traditional way in which we view manufacturing, the law may also have to change once again. Because strict products liability focuses on where products are manufactured and who designs and manufacturers those products, it may not be suited to address how and where 3D printed products are made. These issues include what is a “product,” who is a “manufacturer,” what is the “marketplace,” and who has a duty to warn. Each of these questions raises numerous issues, which will need to be addressed as courts are faced with the potential inadequacies in the common-law. 3D printing manufacturing techniques may also increase the number of possible products and manufacturers (once those terms are defined), so there are more scenarios of who may be liable then with traditional manufacturing techniques, which will result in courts and juries being left to sort it all out.
Beck and Jacobson discuss these issues and the current state of the common-law in depth, which includes analysis of product liability court opinions with respect to 3D printing (so far minimal) and comparable (to the extent possible) products and technologies. While it is still uncertain how products liability law will develop or change, what is certain is that the law will change, and the authors offer their take on the changes that may come.
The potential issues 3D printing may have on products liability law only becomes more multifaceted, as the 3D printed products become more complex and technical, such as medical devices and pharmaceutical drugs and production shifts from central facilities to hospitals/doctors’ offices. As the article explains, 3D printing has perhaps the greatest potential to benefit human lives and health care, even if the exact nature of those developments are hard to predict. But with that great potential comes legal uncertainty, especially since medical devices and drugs are regulated in the United States by the Food and Drug Administration (“FDA”).
One of the legal challenges explored in article is the FDA regulatory framework for 3D printed medical devices. The FDA currently views 3D printing as another form of advanced manufacturing, and thereby fits this technology in its already existing framework. The FDA has already cleared (through its “510(k)” process) approximately 85 medical devices and approved one drug manufactured through 3D printing technology. However, manufacturing truly innovative medical devices—such as bio-printed devices, medical devices made using a patient’s own stem cells—through 3D printing will require more FDA guidance. As the article discusses, 3D printing is on the FDA’s agenda and the agency is continuing to better understand this technology and its place in improving healthcare.
The article not only points out the unknown product liability issues that may result from 3D printing, but also offers strategic insights, which may be useful to mitigate risk or to develop the common-law. The article is a necessary guide for anyone involved in the 3D printing process, including manufactures of 3D printed products, manufactures of the printers, the computer software designers, the manufactures of 3D printing scanners, sellers of 3D printed products (all possible product liability defendants in the future), and even consumers or users of these products.
While the article focuses primarily on tort liability, the authors and their colleagues have published two white papers on similar issues, as well as other key legal issues including intellectual property, constitutional law, commercial litigation, data privacy, environmental effects, health risks in the workplace, and insurance risks and recovery: 3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles and 3D Printing of Manufactured Goods: An Updated Analysis. The article, along with the two white papers, provide a wide-ranging guide on the legal implications of this novel technology across different practice areas.