3D Printing and Product Liability in the U.S. and UK

A layperson or recreational 3D printing enthusiast is not likely to be strictly liable for injuries caused by a defective 3D-printed object, even if he or she occasionally sells products, but a routine vendor of 3D-printed goods might very well be a “seller” within the meaning of the rule. See, e.g., Jaramillo v. Weyerhaeuser Co., 906 N.E.2d 387, 392 (N.Y. 2009) (differentiating “sellers in the normal course of business” from the occasional seller who is “not engaged in the sale of the product in issue as a regular part of its business”) (citation omitted); Agurto v. Guhr, 887 A.2d 159, 163 (N.J. Super. Ct. App. Div. 2005) (vendor is an “occasional” seller, not a commercial seller, if the good's sale “is not part of the 'purpose' of the seller's business”) (citation omitted).

The Consumer Protection Act in the UK imposes strict liability on the manufacturer of the product rather than on the seller (except in circumstances where the seller fails, when asked, to identify the manufacturer ' in which case strict liability passes to them). A layperson who manufactures products via 3D printing, and occasionally sells them, might be able to avail himself of a narrowly drafted defense under the Act if he or she can show both that he/she did not sell in the course of business and did not manufacture with a view to profit.

Is the Defective Object a 'Product' for the Purposes of Product Liability?

Under U.S. product liability law, a “product” is generally understood to be a piece of tangible personal property distributed commercially, which is expected to, and ultimately does, reach the user or consumer without substantial change. See Restatement (Third) of Torts, Products Liability ' 2 (1998).

One important question in the 3D printing arena is whether the CAD rendering for a 3D-printed object is itself a product for the purposes of product liability. To date, no court has squarely addressed this issue. However, courts have suggested that, as a general rule, computer code ' such as a 3D printing CAD blueprint ' is not a product. See United States v. Aleynikov, 676 F.3d 71, 76 (2d Cir. 2012) (proprietary computer source code did not qualify as “goods,” “wares,” or “merchandise” within the meaning of the National Stolen Property Act). Similarly, a 3D-printing CAD blueprint may be considered not a tangible piece of property, but rather intangible content. See Winter v. G.P. Putnam's Sons, 938 F.2d 1033, 1036 (9th Cir. 1991) (intangible content in encyclopedia relied on and causing injury to user was not subject to product liability law); Sanders v. Acclaim Entm ' t, Inc., 188 F. Supp. 2d 1264, 1277'79 (D. Colo. 2002) (“intangible thoughts, ideas, and expressive content” in videogames are not “products” as contemplated by strict liability doctrine).

Finally, the CAD rendering arguably undergoes substantial change when it is converted into an object and is accordingly not likely a “product” itself. See K-Mart Corp. v. Midcon Realty Grp. of Conn. , Ltd., 489 F. Supp. 813 (D. Conn. 1980) (architect's design not subject to product liability law because the design was substantially transformed into physical plant). See generally Nora Freeman Engstrom, Essay, 3-D Printing and Product Liability: Identifying the Obstacles, 162 U. PA. L. Rev. Online 35 (2013), http://bit.ly/2arQVt9; David G. Owen et al., Publications and Products Liability, 141 Products Liability Advisory 1, 1'2 (Nov. 2000) (collecting cases).

A person harmed by a 3D-printed object may pursue another theory: that the 3D printer caused his or her injury. This would require the litigant to establish that at the time the printer left the manufacturer, it was defective in design or manufacture or contained inadequate warnings, and that this defect ultimately caused the person's injuries. See Restatement (Third) of Torts, Products Liability ' 2 (1998) (product must be defective “at the time of sale or distribution”). This approach may only apply to a fraction of would-be litigants, however, since in only a subset of product-related injuries will the defect in the printer be the cause of the injury. It seems more likely that the design of the object will be the cause, not that the printer ineffectively implemented the design. There may also be questions of proximate causation where the injured person never used the printer, but was instead injured by a product created using the printer at some point down the line. Engstrom, 162 U. PA. L. Rev. Online at 38 n.13.

In the UK, for the purposes of the strict liability regime, the term “product” is limited to tangible moveable items. It would not, therefore, include CAD renderings for 3D-printed objects (unless ' at least arguably ' the design was contained on a CD or other durable medium). Outside the strict liability regime, the new Consumer Protection Act 2015 has, for the first time, extended the traditional implied terms in contracts of sale (i.e., that a product must be fit for the purpose for which it is intended, match its description, etc.) to apply to digital content. This means that a person who purchases a defective CAD blueprint (whether provided on a durable medium, via download or otherwise) will have a contractual cause of action against the seller.

As in the United States, a 3D printer will be classed as a “product” under UK law such that, if a defect in the printer can be shown to have caused an injury or property damage, the manufacturer of the printer will be liable.

A Note on 3D Printing and the FDA

The U.S. Food and Drug Administration (FDA) has regulatory authority over 3D printed medical devices and medications. This oversight extends to both pre-market approvals and requirements as well as to post-market surveillance and related obligations. In May 2016, the FDA released a much-anticipated draft guidance for manufacturers creating medical devices by means of 3D printing, indicating that the FDA and other regulators are aware of the unique promises afforded by 3D printing and will be active in crafting design, manufacturing, testing and validation protocols for devices manufactured by means of 3D printing.

The purpose behind the FDA's draft guidance is to outline certain technical considerations associated with 3D printing, as well as to highlight agency recommendations for testing and characterization for medical devices that are made, even in part, via 3D printing. See Technical Considerations for Additive Manufactured Devices, Draft Guidance for Industry and Food and Drug Administration Staff (May 10, 2016). The FDA describes this document as a “leap-frog” guidance, through which the agency can “share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development,” while noting that its recommendations may change as more information becomes available. The FDA accepted comments on the draft guidance through Aug. 8, 2016, and a final guidance is now awaited.

No equivalent guidance has yet been published in the UK (or EU), although it is understood that the issues arising from 3D printing of medical devices are being considered in the context of a new EU Medical Devices Regulation that has been published in draft and is currently being debated.

Conclusion

Given the dearth of cases addressing product liability for 3D-printed objects, it appears that few 3D-printed object users have become product liability litigants so far. End-users of 3D-printed objects face considerable obstacles to imposing strict liability on those involved in the 3D-printing supply chain, but the conceptual framework of the existing product liability regimes in both the United States and UK/EU appears to be applicable and adaptable to the technology. Although the temptation may be to rush to regulate the 3D printing space, over-regulation may stifle innovation in this new, evolving and promising technology. Rather, as the FDA seems to suggest, the better approach may be to ensure that liability and regulatory regimes retain some flexibility to adapt to 3D printing issues as the technology's opportunities and potential problems become better understood.

Joseph G. Falcone is a partner in Herbert Smith Freehills New York LLP, and Laura Paliani is an associate in the New York office. Tony Dempster is a partner in the firm's product liability team, based in its London office. This article was prepared with the assistance of David Bennett , an associate in the London office.