Product Liability : Biocompatible Materials in 3D Printed Products

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As companies continue to innovate, they are turning to 3D printing technology to build customized, patient-matched 3D printed dental and medical devices that incorporate biocompatible materials. Advances in 3D printing technology have made it possible to print human tissue using a combination of stem cells and biocompatible materials. Researchers are working on using 3D printing technology to print organs suitable for transplantation, with the goal of alleviating the shortage of donor organs and saving lives. Earlier this year, Vertex Dental, based in the Netherlands, developed the first CE Class IIa-certified materials, which are biocompatible, and approved for 3D printing dental applications such as dental splints, crowns, and bridges.
Biocompatible materials are not without risks. On June 16, 2016, the FDA issued a FDA Guidance entitled “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process’” to assist manufacturers of devices that come into contact with the human body in evaluating the potential for an adverse biological response resulting from contact of component materials of the device with the body.
For suppliers of these component materials that are shipped to manufacturers to be integrated into end products used by patients, this raises the question of whether a component part supplier may be liable for injuries caused by defects in the end products. In other words, if a 3D printed device that comes into contact with a patient’s body causes an adverse reaction, can the supplier of the biocompatible material be held liable for defects in the finished product that incorporates the material?
In a decision published in May 2016, Webb v. Electric Co., 63 Cal. 4th 167 (2016), the California Supreme Court explained that suppliers of component parts are not liable for injuries caused by a finished product unless (1) the component itself was defective and caused injury or (2) the supplier participated in integrating the component into a product and the integration caused the product to become defect and cause injury. The reasoning is that while component suppliers must adequately warn buyers (e.g., manufacturers integrating the components into end products) of risks associated with the component, it is not reasonable to expect them to monitor all of the potential products that may incorporate their component part and all the potential risks associated with these finished products.
Legal Issues of Healthcare 3D printing
Furthermore, under the bulk supplier doctrine, where a raw material that is a component of a finished product, is supplied in bulk and intended for further processing (e.g., heating, cooling, etc.), the raw materials supplier is not liable for harm caused by the defective design of a finished product. The rationale is that it would be overly burdensome to require raw materials suppliers to become experts on all of the end products in which the raw materials may be used and investigate the use of these materials by manufacturers over whom these suppliers do not exert control.
To mitigates risks of liability, materials suppliers should provide adequate warnings of the inherent risks associated with these component materials to the immediate purchaser of these products and take reasonable measures to ensure that appropriate warnings will be conveyed to those encountering these materials. Suppliers should also disclaim warranties about the suitability of the materials for use in end products. Additionally, suppliers should notify manufacturers that they are responsible for determining the suitability of the component materials for the devices they are manufacturing.

About the Author :

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Farah Tabibkhoei is a member of the Complex Litigation Group at Reed Smith LLP.  Her practice focuses on medical device product liability, managed care disputes, and 3D printing.  Farah can be reached at FTabibkhoei@ReedSmith.com.

Comments

  • For clarity, a Class IIa material is a designation under EU standards. That does not confer any regulatory stature to devices sold in the US. Under FDA regulations, a dental splint is a Class II medical device (different that a Class IIA device under EU standards) and requires a 510(k) for legal marketing in the US. To the best of my knowledge, no company has a materials cleared under 510(k) regulations for a 3D printed dental split.

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