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Farah is a senior associate in Reed Smith‘s Complex Litigation Group. She represents product manufacturers and health plans in areas of product liability, 3D printing, and managed care. She is a member of Reed Smith’s 3D Printing Task Force and closely monitors the complex legal and regulatory issues arising from additive manufacturing, affecting clients across a wide range of industries from healthcare to manufacturing to automotive, to identify risk, develop risk management strategies, and help shape laws and regulations surrounding 3D printing.
As a lawyer who defends product manufacturers, 3D printing is challenging traditional notions of concepts as basic as “manufacturer” and “product.” 3D printing has transformed manufacturing and created a new production ecosystem. There are new players such as 3D printer manufacturers and service bureaus who have, in some cases, displaced the traditional manufacturer, wholesaler, and retailer.
By disrupting manufacturing, 3D printing has created legal uncertainty around issues of product liability. If a 3D printed implant causes an infection, it is unclear who in the supply chain would become liable for the harm. Is it the printer manufacturer? Is it the product designer? Is it the service bureau that printed the product? Which standard of liability applies? Strict liability, negligence, or a new hybrid?
There is a very little precedent on 3D printing product liability issues. As a result, it is unclear whether traditional product liability principles will apply to 3D printed products. Under a strict liability theory, to recover against a manufacturer, a plaintiff must prove that the product was defective and that it caused an injury. Whether 3D printed objects are “products” under this theory is an open question. Courts generally hold that products are tangible materials; electronic files, such as those used to generate 3D printed objects, are generally not considered products. Because the digital file is an integral part of the object itself, however, weighs in favor of finding that 3D printed objects are “products” under a strict liability theory.
One can imagine a scenario where a 3D printing company prints components for integration into a finished product such as a car. If a driver buys a car that uses 3D printed brake calipers and is subsequently injured when the brakes fail, who is liable?
Is the 3D printing company that simply printed the brake caliper strictly liable for injuries to the driver? These issues are not settled regarding 3D printing. In California, manufacturers or suppliers of non-defective component parts are generally not liable if they merely build a component to a customer’s specifications but do not substantially participate in its integration into the final product. To the extent representatives of the 3D printing company trained the car manufacturer on how to incorporate the part into the finished product and oversaw its integration, there is a stronger argument that the 3D printing company bears liability.
Does a 3D printer manufacturer have a duty to warn consumers about the risks of 3D printed parts integrated into finished products? Probably not. Because a manufacturer generally has a duty to warn about foreseeable risks of harm, and a 3D printer manufacturer cannot reasonably foresee the types of products that will ultimately be made using its printer, it is unlikely that a 3D printer manufacturer would be held strictly liable in this scenario.
As 3D printers become cheaper and more advanced allowing for mass production of goods (rather than just prototyping), we will likely see more product liability lawsuits. Traditional product liability principles will have to transform to account for 3D printing — basic concepts such as product, manufacturer, and commercial seller, will be redefined. The duties of a 3D printer manufacturer, service bureau, and product designer will become clearer.
In the EU, product liability laws are receiving closer scrutiny in response to disruptive technologies. The European Commission is currently assessing its longstanding product liability law, Directive 85/374/EEC concerning Liability for Defective Products, to assess whether it serves its purpose in light of new technologies such as 3D printing. By soliciting the input of industry stakeholders, the Commission hopes to identify needed improvements.
Aside from its transformative impact on existing product liability laws, what I find most exciting about the future of 3D printing, is its potential to significantly improve the quality of patient care. Hospitals will be able to print customized, patient-matched printed devices and implants, on-site. For patients who rely on medical devices, better fit means better comfort, less complications, and an improved quality of life. For those who are in need of an organ replacement, 3D printing will one day allow us to print organs using the patient’s own cells, eliminating the need for donor waiting lists, extending one’s life expectancy, and lowering the risk of the body’s rejection of the organ.
Although there are many benefits of 3D printing, it will take a few years before we see 3D printing commonly used in hospitals for several reasons. As a starting point, the costs of 3D printers remain high. Additionally, there is a shortage of skilled technicians in the industry. Further, 3D printed devices and related procedural costs are not yet covered by health insurers. There needs to be greater research and evidence regarding the safety and effectiveness of 3D printing in order for health insurers to cover the costs of 3D printed devices and procedures.
The rapid pace at which 3D printing technologies, materials, and applications are advancing across industries makes 3D printing a regulatory moving target. 3D printing regulations are just beginning to emerge. In May 2016, FDA released its draft guidance, Technical Considerations for Additive Manufactured Devices, which provided the FDA’s “initial thinking” on design, manufacturing, and device testing considerations for 3D printed medical devices. Prior to releasing the draft guidance, the FDA held a 3D printing workshop to provide a forum for FDA, medical device manufacturers, 3D printing companies, and academia to discuss 3D printing and address its challenges. FDA regulations on 3D printing have not been released yet.
The private sector will play a key role in shaping regulations for 3D printing. Companies such as UL (formerly Underwriters Laboratories) are already developing product safety standards for 3D printing. In February, UL held a Science Safety of 3D Printing Summit, regarding the toxicity of particle emissions released by 3D printers. Following the Summit, stakeholders committed to developing an ANSI standard to establish safe levels of printer emissions for use of 3D printers indoors. Continued research and collaboration among industry leaders, manufacturers, academia, and government will be crucial to any regulation of 3D printing.
More information about Reed Smith is available here. For more information regarding 3D printing legal issues, you can download the latest version of Reed Smith’s 3D printing white paper here.
This is a guest post in our series Industry Insiders. if you’d like to participate in this series then contact us for more information.
