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 Prining: 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.

Next month we will take a more in-depth look at the nuances of U.S. and UK law regarding 3D-printed products, and we will discuss the FDA's recent draft guidance concerning the technology and its use in the manufacture of medical devices.

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 Herbert Smith Freehills' product liability team, based in its London office. This article was prepared with the assistance of David Bennett, an associate in the London office.