Three-dimensional (3D) printing involves building solid, 3D objects from digital models using an additive process in which successive layers of material are assembled on top of one another to create the desired device. Materials involved in printing include plastic, metal, medication, and even human tissue. Currently, these devices are particularly expensive. However, as 3D printing becomes more accessible to more hospitals and physicians, it will present significant liability questions for anyone injured by medical devices created by 3D printers.
Traditionally, if a manufacturer creates a 3D-printed device, the manufacturer is the one subject to product liability claims; however, when a hospital or doctor prints the equipment at his or her own facility, who is liable if the device causes a patient an injury?
When devices are printed via a 3D printer, they are usually customized for a variety of medical uses, including surgery preparation, prosthetics, casts, braces, and so on. They may one day even create organs.
As the law stands, applying product liability principles to hospitals and doctors printing their own medical devices might be difficult. Under current product liability laws, anyone injured by a defective product can hold the manufacturers and sellers of the product strictly liable as long as they engaged in the business of selling the product. However, who is the manufacturer if the product was created by a 3D printer in a hospital?
Doctors and hospitals cannot be held strictly liable as suppliers of medical products; instead, they are considered similar to consumers or users of a product. Likewise, if there is a defect in the product traceable to the software code, most believe software codes are not considered products and, therefore, software designers are not responsible for the errors of 3D design products.
The organization most likely to be able to protect patients is the Food and Drug Administration (FDA). The FDA can impact defenses assert in product liability claims. However, 3D-printed medical devices present a unique challenge for the FDA, and many issues continue to remain unclear.
Because it is widely anticipated hospitals and doctors will be using 3D printing to increase production of 3D devices on-site, patients injured by these devices will face significant legal difficulties.
If you were injured by a medical device, don’t hesitate to give our skilled Sedalia product liability lawyers a call. Kempton & Russell has more than 60 years of legal experience to offer your case. We have an impressive history of successes in a wide range of personal injury, product liability, and medical malpractice claims. Let us see what we can do for you.
Contact us at (660) 722-4115 or fill out our online form to schedule a free case consultation with us today.