With each passing year, the long-predicted aspirational advantages of 3D printing in the life sciences industry become a reality. Forecasts of large scale printing operations at or near major hospitals are fulfilled. Visions of bioprinted organs have become a reality. 3D printing is reaching the lofty potential projected by the life sciences industry years ago. However, the topic of litigation risks with 3D printing in the life science industry is often overlooked.
The role of 3D printing in response to the COVID-19 pandemic provides a publicized example of both the unparalleled benefits and potential litigation risks with 3D printing. At the start of the pandemic, the United States scrambled to address the personal protective equipment (“PPE”) shortage. While traditional manufacturers struggled to meet demand, 3D printing shoe manufacturers and even college students with a 3D printer in their garage were able to quickly obtain PPE CAD files and raw materials and immediately manufacture gowns and face shields. It was a public glimpse into the unparalleled benefits of this innovation.
Yet, the widespread use of additive manufacturing by companies and individuals outside of the life sciences industry also underscores the potential litigation risks with 3D printing. With a technology where barriers to market entry are somewhat minimal, the variables in manufacturing are multiple. Additionally, the parties involved in the chain are sometimes unknown to each other. Therefore, there is an increased potential for a catastrophic event to occur, with multiple parties possibly exposed to tort liability.
While product liability laws are well established for the traditional design and distribution chains, the uniqueness of 3D printing will lead to many challenges and unknowns that do not fit into the current legal landscape. This article will discuss some of those unknowns and identify challenges and potential areas of increased litigation risks with 3D printing for the various companies and individuals involved in the life sciences additive manufacturing chain:
(1) the CAD file and/or product designer;
(2) material suppliers;
(3) software providers/manufacturers;
(4) printer manufacturers;
(5) the individuals or entities printing the products.
A Brief Products Liability Overview
Although there are a number of nuances and exceptions under various states’ laws, a basic understanding of product liability will help guide entities as they develop labeling, quality control, and other procedures.
In general, product liability exposure attaches when a product is deemed to be defective and that defect caused the alleged injuries. A product may typically be found defective in one of three ways—design, manufacture, or labeling.
Generally, a design defect is found when the manufacturer could have reduced a foreseeable risk of harm by adopting a reasonable and economically feasible alternative design. Many states also consider design defect(s) by evaluating whether a product is “unreasonably dangerous” after weighing the utility of the product against its risks.
A manufacturing defect claim requires proof that the product at issue somehow deviated from its intended design. For example, a deviation could be that one specific product was not manufactured within the tolerances specified in the design drawings.
Finally, a defect in labeling, commonly referred to as a failure to warn, typically requires proof that a manufacturer failed to provide an adequate warning when it was known or reasonably ought to have been known that a product was unsafe for use by its expected and intended users.
Again, every state has different laws and wrinkles that may impact what steps an entity considers in trying to protect itself from liability. Nevertheless, this general overview will help frame the discussion and analysis set forth below concerning litigation risks with 3D printing in the life sciences industry.
Unknowns with Regulatory Compliance and Industry Standards
Before discussing issues specific to each entity in the 3D printing chain, one general issue is exposure created by a lack of established FDA regulations and industry standards. Generally, compliance with FDA, ASTM, and/or ISO regulations and standards are important shields for companies to employ in defense of a lawsuit. Even if your company or entity is not required to comply with FDA regulations, well-established guidance helps companies understand issues and expectations. With 3D printing, however, it does not have the same extensive history or regulatory framework safety net.
On December 5, 2017, the FDA adopted the final form of its guidance document on 3D printing entitled “Technical Considerations for Additive Manufacturing.” The guidance does not cover the point of care printing nor bioprinting issues. The guidance does not establish specific requirements but rather describes issues to be considered and addressed by manufacturers during product testing and manufacturing development stages. While the guidance does suggest having procedures and validation processes to address certain issues unique to 3D printing—such as the use of reused materials, software integration, and build path variables—it does not identify any specific “how to’s” for those procedures or tests. Without such guidance or applicable standards, manufacturers are in the unenviable position of having the FDA identify a concern, but not offering any consensus standard for addressing it.
ASTM International has developed some consensus standards for additive manufacturing. Committee F42 has developed standards for testing and evaluating methods for the materials used as well for the manufacturing processes. However, there are no specific standards addressing many of the issues and validation processes identified in the FDA’s guidance.
Unknowns Facing Each Entity Involved in the 3D Printing Chain
Traditionally, products liability exposure falls on the device manufacturer and may extend to other parties in the chain of distribution depending upon the applicable state’s laws. 3D printing, especially in the point of care context, challenges this general tenet, as questions arise regarding what is the product (i.e., the CAD file or the finished printed device) and who is the manufacturer (i.e. the company designing the CAD file, the printer company, or the hospital)? Responses to those questions could be a textbook chapter by themselves. At this stage of 3D printing, however, parties cannot assume how these questions will be answered or how the laws will develop. Instead, all parties involved in the 3D printing process, from suppliers and vendors through to the party doing the final printing, should carefully consider these unknowns and ways to best protect themselves against uncertainty.
Litigation Risks for CAD File/ product specifications designer
The primary challenge for the “designer” of point of care printed products is that the “product” being sold is not the finished device or drug, but rather a CAD file. The pre-market testing and post-market quality control typically required by the FDA cannot be performed by these design companies with the same predictability as with traditionally manufactured products. For example, a tenet of testing in the device industry is testing the “worst-case scenario”—meaning testing the product size with the highest torque or the most stresses. But with the point of care printing, allowing for customization of devices and guides to fit a patient’s specific anatomy, the “worst-case scenario” is limitless.
To address this issue, as well as other potential concerns, design companies should consider issuing warnings and instructions with the CAD file addressing unknowns and limits. In the above example, the designing company may want to indicate what “worst-case scenario” they have tested, and which specifications would exceed any completed testing. Further, the company may also want to indicate other important factors or variables in the products they have tested.
For example, if all testing and design work was done using a precise build path or print environment, such specifications should be communicated. The same holds true for the materials used in tests, how much recycled print materials, if any, are advisable, and the significance, if any, of temperatures and areas to avoid for the physical placement of the printer (i.e. away from windows, air vents, etc.).
By way of further example, design companies may also want to detail their recommended post-processing steps such as the removal of print residues or heat treatments designed to remove residual stresses. In sum, the challenge for companies selling design files is to understand what conditions were critical to obtaining a finished product within specifications and to carefully communicate those conditions through labeling. This is a unique challenge to the drug and device industries where manufacturers are not accustomed to selling anything other than a finished product.
In addition to warnings and instructions, sellers of CAD files may also want to carefully consider the breadth of distribution. While widespread sales may be attractive to a company, when the distribution of the CAD file becomes so broad that it is difficult to monitor or control who is using it, there is an increased chance that an issue may occur. This not only increases concerns with the protection of intellectual property, but it also raises product liability concerns. For example, it becomes more difficult to ensure updated warnings or changes in labeling are properly communicated to the consumer base when that base is largely unknown.
Litigation Risks for 3D Printing Materials suppliers
Raw material suppliers also face challenges of their products—powders, fibers, or other print materials—being used for applications or in ways outside of what may have been tested or intended. For example, one issue identified by the 2017 FDA guidance concerns re-used print materials, such as powders. The FDA guidance document recommends that printing companies have controls in place for the percentage of recycled powders permitted in any print. Although the FDA guidance is directed to the design and manufacture companies, the provider of these materials may want to consider issuing warnings or disclaimers accompanying their product if it has knowledge or is aware of uncertainties with using the product over multiple prints (i.e. concerns with properties of the material changing if heated, exposed to air, etc.). Other warnings and instructions, including recommendations for the temperature to maintain the materials, may also be considered.
Further, when negotiating supply contracts with manufacturers or the user doing the printing, material providers will want to consider indemnity and defense provisions, offering protection from the buyer if the supplier is named in any lawsuits resulting from the use of the materials.
Litigation Risks for Printer manufacturer and software programmer/manufacturer
Software providers and the makers of traditional manufacturing equipment are not often the target of product liability lawsuits. However, given that the printer and the software are two variables in the manufacturing process of 3D printed devices, it may still be advisable to carefully consider warnings, instructions, and contractual protections when entering the 3D print market.
The FDA, in its 2017 FDA guidance document, spends several pages detailing considerations to ensure proper software and printer integration. This attention from the FDA suggests recognition on its part that glitches in these systems can lead to potential manufacturing deviations. Software providers and printer manufacturers may consider warnings to include regarding the integration process, advising against any alterations to printers, and suggestions about maintenance and updates.
Similar to material providers, software providers and printer manufacturers may also want to negotiate indemnity and defense provisions when contracting with any medical device manufacturer or point of care printer.
Litigation Risks for Party printing the device
While all entities face new challenges and unknowns with compliance and liability protections regarding 3D printing, the end manufacturers may often be the group tackling these challenges for the first time. In the point of care printing scenario, the hospital may be the entity printing the finished device. Typically, a hospital is not concerned nor experienced with product liability issues. However, with 3D printing, they may become the most obvious target if legal action is pursued. Currently, there are many unknowns with how hospitals or other entities printing the actual product may be treated by regulators or under the law. The 2017 FDA guidance document expressly excludes its application to point of care printing. Further, case law in this area is not developed, thus questions of whether the entity printing the device would be considered a manufacturer or even what is considered the “product” is unclear.
With all of these uncertainties, entities considering printing medical devices must carefully evaluate the potential exposure and risks before proceeding. If the entity proceeds with the point of care printing, there are a number of procedures and safeguards that must be considered. For example, point of care manufacturers should consider adopting procedures and quality controls to ensure compliance with CAD files, printer, software, and material warnings and instructions. They will also need to consider a “post-manufacture” inspection process and controls designed to verify a product was printed as intended and in compliance with instructions.
3D printing is an exciting innovation with endless potential. It is tempting to want to get ahead of the competition and jump into the market without carefully considering the risks. There are many unknowns in how potential liability exposure could play out in the future with 3D printing. However, by considering basic product liability concepts and employing time-tested protections, companies may be able to reduce future exposure against litigation risks with 3D printing.
About the Author:
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. Click here to read more about Duane Morris’ medical device litigation practice.
Sean K. Burke
Partner and Vice Chair of Products Liability and Toxic Tort Trial Division
Duane Morris LLP