3-D printing—the process of making a three-dimensional solid object of virtually any shape from a virtual computer model—is quickly becoming a reality. This evolving technology allows individuals to print physical objects based on computer blueprints in almost real time. In some cases, individuals design their own products—but there are many pre-designed products available for individuals to print as well. According to a New York Times Article, these printers use “heated plastic—applied layer by layer to a heated glue-gun-like extruder—to turn designs created on a computer into real objects.” The New York Times has predicted that 3-D printers will “become part of our daily lives…much sooner than anyone anticipated.” President Obama noted in his 2013 State of the Union address that 3-D printing “has the potential to revolutionize the way we make almost everything.” 3-D printing offers to personalize the manufacturing of products in two ways: 1) it lets companies such as medical device manufacturers personalize medical devices for individual patients in novel ways; and 2) it lets individuals manufacture their own products.
There are already several applications of 3-D printed products in the field of medical devices. Recently, doctors in Michigan 3-D printed a tracheal splint and implanted the device into a 3-month old boy with a rare bronchial condition. The doctors say the 3-D printed device saved the boy’s life. The FDA provided emergency investigational device exemption clearance for this device. Doctors have also replaced 75 percent of an injured man’s skull with a 3-D printed implant. The FDA has also reported that a South African man recently created a 3-D printed prosthetic “Robo-Hand” that costs about $100 to print, is available for free on the internet, and allows greater mobility than most approved prosthetics. The FDA has recently undertaken efforts to address how it will manage 3-D printing and its impact on medical device approvals. As 3-D printing technology continues to evolve to meet consumer needs, the FDA will have to determine how to regulate a wide range of new medical devices being developed.
3-D printing technology also offers to let individuals become manufacturers of their own products. Home 3-D printers are becoming more affordable—a 3-D printer called the MakerBot Replicator Mini is available for $1,375. MakerBot, a manufacturer of home 3-D printers, markets their products as being able to print “household items and replacement parts.” However, the range of items being 3-D printed is not limited to household items. In recent years, 3-D printing has produced houses, bionic ears, and a working handgun.
If individuals are 3-D printing products such as weapons and safety equipment such as bicycle helmets, who is held accountable if someone is injured while using these products? If 3-D printing does catch on, there could be significant implications for the field of product liability law. In a very general sense, product liability law can impose liability against manufacturers, distributers, suppliers, retailers, and others who make products available to the public. If 3-D printing becomes more mainstream—as many predict it will—identifying those potential defendants may not be easy.
Nora Freeman Engstrom, a Stanford Law School professor, has warned that 3-D printing may make strict liability product liability lawsuits obsolete. Professor Engstrom points out that product liability lawsuits are directed at commercial manufacturers—those “engaged in the business of selling or otherwise distributing products”—and would likely not cover individuals equipped with 3-D printers. Professor Engstrom suggests that if an individual prints a potentially dangerous product in their kitchen or countertop and then sells that product to another individual who is then injured by the 3-D printed object, the injured party will not be able to prevail in a strict liability product liability lawsuit against the printer of the object—unless that individual is determined to be a “commercial seller.” Professor Engstrom also suggests that in order to prevail in a product liability suit against the company that manufactured the 3-D printer itself, the plaintiff would have the burden of showing not just that the printer produced a defective product, but rather that the printer itself was defective at the time it left the printer manufacturer’s possession. Additionally, Professor Engstrom notes that the plaintiff would likely not be able to prevail against the author of the digital blueprint for the product, as such coding is not considered a product (i.e., tangible personal property).
If 3-D printing continues to become more mainstream, FDA regulation of medical devices and products liability law will both have to evolve to adapt to this new technology and the issues it poses in the near future.
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