3D Printing: New Layers of Medical Advances

3D printing is no longer a far-fetched idea; it is a reality that is becoming more evident in multiple areas of our life. Just like any other new technology, it brings with it an array of legal challenges.

An American engineer, Charles Hull, first invented additive manufacturing in the 1980s. This is the process used in 3D printing. 3D printers work like inkjet printers, but unlike our household friends, they deposit the desired material in successive layers to create a physical object. 3D printers use a CAD (“Computer Aided Design”) file or a 3D scanner to create or copy objects that would otherwise be impossible to build. Printing can be done with polymers, resin, titanium, precious metals and even human cells. Among the objects printed today are figurines, jewelry, machine parts, architectural models and even various medical devices. These medical devices vary in sizes and shapes, as well as the way they are used.   

The number of uses of 3D printers in health care ranges from small everyday devices to special, out of the ordinary, life-saving implants. 3D systems, a company started by Charles Hull, contributed to the development of Invisalign, clear customized teeth braces. The company also developed spinal braces for young adults with scoliosis, which unlike the old bulky brace, are made of breathable material and are easily worn under clothing.

This technology is not limited to medical devices that treat the human body externally. Doctors at Morriston Hospital in Wales, used a 3D printer to produce titanium replicas of an injured motorcyclist’s facial bones, and successfully reconstructed his face. In the United States, Dr. Meara, of Boston Children's Hospital, used a 3D printed skull model to prepare for a highly delicate Tessier facial cleft surgery that realigned 2 year-old Violet Pietrok’s facial bones. In addition, University of Michigan Health System doctors printed a customized splint for a newborn with a collapsing trachea. Without 3D printers, these patients would have had a small chance of recovery.

The most revolutionary project is conducted at Harvard University Wyss Institute for Biologically Inspired Engineering. Dr. Jennifer Lewis, with a team of researchers, developed Pluronic Ink, a gelatinous material that turns into liquid when frozen. This “fugitive ink”, as Dr. Lewis calls it, allows the researchers to print intricate networks around the ink that, once removed in liquid form, leaves a network of channels that can simulate vascular networks. These networks are then injected with endothelial cells, the cells that line the inside of blood vessels, and they multiply, turning the empty channels into live blood vessels.  Dr. Lewis hopes the 3D printing of live human tissue will allow  pharmaceutical companies to test how the drugs are metabolized and potential side effects.

Despite the benefits of this technology these exciting new developments have the potential to spur legal issues that will touch multiple areas of the law.   For example, 3D printing has already touched the field of patent law, and it is likely to impact copyright law.  Further additional product liability lawsuits and FDA limitations on 3D printing can be expected as well. 

3D systems have filed at least two patent infringement suits, one against AaronTech Labs, and another one against a recent Kickstarter funded Formlabs. There is no case filed for a patent infringement of an object, but legal scholars are of the opinion that this will occur once 3D printers reach commercial scale.  Patient infringement litigation can be very expensive as the parties argue over each requisite element of patentability, with the burden of proof on the patent holder.

Current bio-medical uses of 3D printed implants and devices may begin to challenge the way FDA approves traditional medical devices. The Federal Food, Drug, and Cosmetic Act allows exceptions for health care providers to use unapproved medical devices, when necessary to save a patients life. University of Michigan used those guidelines to obtain an emergency approval for a bio-resorbable airway stent for a baby suffering from a life-threatening condition. However, if this practice becomes routine, the FDA will surely take these exceptions away, and into the inert hands of federal legislature.

Concerning 3D printing, the main issue is whether hospitals, that are not strictly liable as suppliers, would be considered manufacturers, since the 3D printers that produce implants and medical devices are usually owned by the hospitals. Restatement (Second) of Torts requires the seller to be “engaged in the business of selling such a product.” Under this requirement, hospitals would likely not be held subject to strict liability.

Who, then, would be liable, manufacturer of the printer, or the developer of the software used to design and print the objects? Attaching strict liability to the manufacturer for every product the printer produced would be excessive, and could render 3D printing uneconomical.  Software designers have traditionally not been held strictly liable.

At the moment, 3D printed devices are opening new avenues of healing that were not available before, but as in all new technologies that cross from the drawing board to mainstream use, the laws and the litigation will shape the impact 3D printing will have on the medical field in the years to come. 

Nesko Radovic is a current 2L at DePaul University College of Law. Mr. Radovic completed his undergraduate degree at Strayer University in Washington, D.C. Mr. Radovic hopes to practice in Health Law after graduation.