Emerging Legal Issues in 3D Printing and Product Liability

It is the latter question that this article considers, from the perspective of United States law as well as the regulatory environment in the United Kingdom. To date, product liability case law concerning 3D printing is sparse, owing at least in part to the fact that 3D printing technology is still relatively new. It is, accordingly, an opportune time to examine the current state of the law governing product liability claims as applicable to 3D printing, and to consider where the law might go (and where it should go) in the future.

3D Printing Technology and the Supply Chain

To create an object using a 3D printer requires that the object design be rendered in a computer-readable format, by using computer-aided design (CAD) software. The printer then uses the CAD rendering as a blueprint and prints the object by applying successive layers of material to create the particular three-dimensional shape. Users may create their own 3D designs using CAD software. Some printers can even create a three-dimensional blueprint of an existing object by scanning its external shape. Users can also obtain 3D designs from a third party, since the computer-readable blueprints can be easily shared electronically. Various websites make 3D printing blueprints available to the public, some for a fee.

The application of product liability principles is perhaps uniquely challenging in the 3D printing space because of the supply chain and business models involved. The parties involved in the 3D printing supply chain ' any of whom might be implicated in the event of a potential product liability issue ' include:

• the manufacturer or supplier of the 3D printer;
• the manufacturer or supplier of the 3D printing material (essentially, the “ink” in the printer);
• the printer owner;
• the person who designed or sold the original object upon which a 3D printing design is based;
• the person who created or shared the CAD blueprint of the object;
• the person who created the object using the printer; and
• the person who sold the 3D-printed object.

Given this, problems with 3D-printed objects can arise in a number of different ways. For instance, the fundamental design of the object may be defective ' including where the original object upon which the design is based is defective ' or the design may be defectively rendered in the CAD blueprint. Even where the design and CAD rendering are sound, the 3D printer may be defective such that it fails properly to implement the design in creating the object. The printing material, or ink, may be defective in a manner that in turn renders the object defective. Alternatively, the 3D printer and/or printing material may be sound, but result in a defect due to human error at various points in the printing process. See, e.g., Shen Wang, Comment: When Classical Doctrines of Products Liability Encounter 3D Printing: New Challenges in the New Landscape, 16 Hous. Bus. & Tax L.J. 104 (2016).

Product Liability Law As Applied to 3D Printing

Generally, product manufacturers and sellers can be held liable under the laws of the various U.S. states for injuries caused by defective products under a fault theory (negligence) or a no-fault theory (product liability or strict liability). A strict liability claimant need only establish that the product was defective at the time it was supplied by the manufacturer, without regard to the manufacturer's conduct. A product is “defective” if it has a manufacturing or design defect or is accompanied by inadequate warnings. See Restatement (Third) of Torts, Products Liability ' 2 (1998). As discussed below, in the context of 3D printing, plaintiffs are likely to face at least two significant hurdles: first, whether the vendor is a commercial seller subject to strict liability; and, second, whether the object is a “product” subject to product liability standards.

The position in the UK is broadly similar. Consumers who have been injured (or suffered property damage caused by a defective product) are able to recover damages from the manufacturer on a strict liability basis (i.e., without having to prove fault on the part of the manufacturer). A product is defective for these purposes if it does not meet the standard of safety that persons are generally entitled to expect. The adequacy of any warnings accompanying the product will be relevant. The strict liability regime is set out in the Consumer Protection Act 1987, which brings into effect relevant European Union (EU)-level law. Accordingly, the position will be broadly similar in other EU member states (though, given the UK's recent vote to leave the EU, it will not be subject to future changes in the EU-level regime). Alongside the strict liability regime, manufacturers owe a tortious duty of care to the end users of a product, which may give rise to a claim if the manufacturer's negligence leads to a product being defective or dangerous.

Who Is the Manufacturer And/or Seller?

Product liability law in the United States generally provides that one “engaged in the business of selling or otherwise distributing products who sells or distributes a defective product is subject to liability for harm to persons or property caused by the defect.” Restatement (Third) of Torts, Products Liability ' 1 (1998). This may include manufacturers, distributers and wholesalers. Whether an end-user can recover under a strict liability theory depends on several factors, including whether the “seller is engaged in the business of selling” the product ' that is, whether the seller is a commercial seller. Restatement (Second) of Torts ' 402A(1)(a) (1965).

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 video games 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 movable 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 “leapfrog” 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 was accepting 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-prnting 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. 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.