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
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
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.