Additive manufacturing, or 3-dimensional (3D) printing, continues to rapidly develop across a number of industries. The medical device industry has championed some of the greatest innovations with this technology, as manufacturers and material suppliers realize the unique benefits and advantages to using 3D printing to provide unparalleled patient specific care.
As innovation continues to explode, industry standards and regulations lag behind. The unique aspects and potential availability of additive manufacturing raise novel products liability issues that may impact traditional product-liability litigation doctrines.
Standards and Regulations
The U.S. Food and Drug Administration (FDA) and leading industry standards committees have drafted guidance and standards relating to additive manufacturing. On December 5, 2017 the FDA adopted in final form its guidance document on 3D printing entitled “Technical Considerations for Additive Manufacturing.” The guidance does not cover point of care printing nor bio printing 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 left 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 not specific standards addressing many of the issues and validation processes identified in the FDA’s guidance.
With endless possibilities offered by 3D printing, the potential issues and impact on products liability are unknown and unlimited when considering the three primary theories of products liability law—design defect, manufacturing defect, and failure to warn.
For example, a key element of a design-defect claim is the availability of a feasible alternative design. With 3D printed products, plaintiffs’ counsel might argue that the same product could be designed using traditional manufacturing processes. Manufacturers might need to identify a distinct design advantage from 3D printing a product as opposed to using traditional methods. By recognizing the justification for using additive manufacturing in the early design and development stage, manufacturers may best position themselves to defend against this potential feasible alternative design argument.
The number of new manufacturing variables introduced by 3D printing may also provide plaintiffs’ counsel with many avenues to consider a manufacturing defect claim. Variables unique to 3D printing, such as recycling unused powder or materials from one print to the next, clearing materials or powders from a previous print, printing or software glitches, and deviations in build paths may increase the potential that deviations from design specifications occur during the manufacturing process.
3D printing also raises new issues for failure-to-warn claims. Under current FDA framework, instructions for use are submitted to, and either reviewed or approved by, the FDA prior to the marketing of a device. But with 3D printed products, especially in the point of care setting, the following questions arise
- Will instructions for use be required where the implant is being manufactured at a hospital or nearby printing hub?
- If so, should those warnings and labels accompany a CAD file, for example, that contains the printing specifications?
- Or will the designers of software used to image the patient’s anatomy be required to issue warnings?
- Or perhaps the 3D printers will be required to have warnings and instructions for use?
The absence of regulatory or consensus guidance and standards on these issues relating to point of care printing may open new avenues of argument for legal liability.
We will continue to keep a close eye on FDA guidance and emerging ASTM standards as they relate to additive manufacturing, as such developments will likely serve as a barometer for the treatment of 3D printed devices in products liability law.