For as long as cars have existed, three fundamental truths appeared to be eternal. First, every car contains safety critical components, second these components are mostly metal and third, they are manufactured by one of two methods—stamping or cold forming. These eternal truths always led to an equally durable legal reality, that if the safety critical component fails the manufacturer will be liable to the injured party. It’s hard to think of a more trite and dependable set of principles. But these timeless precepts are about to become disrupted as the automotive industry continues to explore the innovation of 3D printing. Also known as additive manufacturing, 3D printing is attractive to automobile manufacturers and other entities looking to expand their footprint in the industry because of its unique advantages—namely reduced costs, reduced times for production, and customization. With these novel benefits, however, come unprecedented liability questions.
Imaginary Case Study
To demonstrate this let’s take an imaginary future scenario. A driver takes his truck in for service and discovers that it needs new brake discs. Unfortunately, these are out of stock and there is a three day wait to source the genuine ‘OE’ (original equipment) parts from the manufacturer. Since these are safety critical components, the customer wants OE parts, but he also does not want to wait 3 days. Now, suppose the dealer offers a solution: he has a 3D printer which he purchased online, the necessary print materials from a third party vendor and a CAD file provided by the manufacturer. With these assets he offers to create a set of brake discs the same day, by 3D printing. This sounds good to the customer, who happily accepts. At this point, this story looks like a case for the virtues of 3D printing. Aluminium is difficult to work with by conventional means, but it is ideal for 3D printing, and parts can be printed, even customized, on demand. So far so good. Now suppose that a week later the brake discs underperform and lead to a catastrophe.
Let us pause to remember the steps which manufacturers follow to create safety-critical parts. They can be summarised as 1) material selection 2) design 3) manufacturing 4) testing and 5) quality assurance. These five stages will be recognised as the conventional ‘process pentagon’. But in this case, none of these things have happened. The manufacturer may have provided the CAD file but had no other direct involvement in the part or its manufacture. The component may not have been made from the selected material in accordance with the design, there was no production control, or post manufacture testing or quality assurance.
Key Issues & Uncertainties
From a litigation standpoint, who is responsible for the accident? This question introduces a number of variables which never existed in the automobile industry under the traditional manufacturing model. Were these brake discs even original equipment? Was the vehicle subject to an unauthorised modification such, quite apart from invalidating the warranty, it relieves the manufacturer of all liability?
The uncertainty does not stop at these threshold questions about where liability rests in the design and manufacture process. The above scenario also leads to several unique questions which span the main three theories of products liability law – defect in design, manufacture and warning.
In terms of design defect, the primary issue is who is the designer? Assuming the manufacturer who provides the CAD file is considered a designer, then design defect inquiries will focus on the testing done by the manufacturer before releasing that CAD file. But with 3D printing, how does the manufacturer know what exact materials, manufacturing environment, and printer the dealer will use? Does the manufacturer need to test for all of these “worst case scenarios”? Perhaps not, but then the manufacturer will need to provide adequate warnings on these issues, which will then lead to potential ‘failure to warn’ claims.
Warnings and disclaimers to customers are critical for manufacturers. But with 3D printing parts, the warnings accompanying the CAD files are equally critical. The customer is likely to be a dealer or some other trade intermediary, not an end user. As noted above, there are a number of variables that could greatly impact the manufacturer of a 3D printed part. As a designer of the CAD file it is nearly impossible to envision, let along test all of these scenarios. Thus, it will be critical, but not easy, to give clear warnings around many variables, such as the conditions in which 3D printed parts have been and should be tested.
For example, a critical factor in 3D printing is the build path, i.e.,the physical path the printer takes to build a product—clockwise, diagonal, etc. Because the materials used are likely to be hot when applied, how long a layer has to cool before the next layer is added could greatly impact the strength of the part. The manufacturer may have tested the design with one ideal build path, but if that build path is not exactly followed by the dealer, the integrity of the part may be impacted. The manufacturer will therefore need to provide clear and precise warnings on the exact build path to be used and the risks and concerns if going outside of those specifications. Build path is just one example of a variable to be warned against. Specifications will also need to be considered regarding the materials selected, the climate in which the printing takes place, and ensuring integration between the printer and the software selected. Manufacturers may also seek to shift testing responsibility to the dealer, and with justification.
To take another example, 3D printing of metal parts is often done using raw powder which is expensive. Each print will likely leave unused powder. In other industries using 3D printing, this material is often “recycled” for use in a later print. For medical devices, for example, the FDA has issued draft guidance that a device manufacturer should provide specific warnings regarding the maximum percentage of recycled powder that can be used in any print. Otherwise, a disproportionate amount of recycled powder, that may have already been altered or compromised by being exposed to a prior printing environment, can lead to a deviation from the intended specification of the product.
Similarly, other variables that could impact the integrity of a printed part include the age and maintenance of the printer used, integration of the printer and selected software, the temperature where the print is performed, and any cross contamination of the powder with material or powder inadvertently left in the machine from a prior print.
3D printing is ripe for potential manufacturing defect claims given the number of variables in each print. Dealers, manufacturers, printer manufacturers and material vendors all need to be aware of these variables, and be sure to have warnings and safeguards in place for preventing, or at least mitigating, the risk of manufacturing deviations.
Despite these unique challenges, 3D printing remains an exciting opportunity in the automotive industry. The opportunities and potential of this innovation are seemingly endless and the continued evolution of the technology will benefit both manufacturers and consumers. Nothing in this article is intended to dampen the spirits of those pursuing this innovation. However, such enthusiasm should not blind manufacturers from seeing unique potential liability risks, especially where the innovation is moving quickly and is outpacing the regulation. This makes it all the more critical that all entities in the design and manufacture chain carefully evaluate each step of the process and implement necessary safeguards and warnings to best protect themselves against unique products liability issues and challenges that may arise if a catastrophe occurs.
About the Authors
Sean Burke is the partner and vice-chair of the products liability trial division at Duane Morris. He is in the firm’s Washington, DC office. Mr. Burke’s practice focuses on the representation of manufacturers of medical devices in product liability cases across the country, including in consolidated multi-plaintiff matters in both federal court and state courts. His experience includes the defense of large total joint replacements (hips, knees, ankles, and shoulders) and resurfacings, tissue matrices and patches, fusion plates, and surgical instruments.
He has a particular interest and focuses on additive manufacturing, consulting, and advising clients on best practices in the early stages of development to reduce the risk of product liability exposure. He has tried medical device cases before juries in both state and federal courts while also handling numerous mediations. He works closely with scientific experts to advance causation and liability defenses in the areas of biomechanical engineering, toxicology, histology, epidemiology, orthopedic surgery and FDA regulations.
Alexander M. Geisler is a team lead for the Duane Morris Transportation/Automotive Industry group. He practices in the areas of commercial litigation and dispute resolution, with an emphasis on product compliance, safety compliance, and product liability. Mr Geisler is well-known in the auto industry as a manufacturer’s lawyer. He defends auto makers and suppliers in litigation all over the world, both as a trial lawyer and a defence coordinator. His workplace is largely field-based, at manufacturing plants, accident locations and courtrooms. Mr Geisler also advises manufacturers on regulatory and ethical issues affecting autonomous vehicles, and he is retained for future-proofing projects, investigations, process reviews and silo-busting exercises, as well as supporting recalls and managing critical concerns.
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