They’re futuristic devices that can produce tangible, solid objects from a digital file. Now, 3D printers have attorneys in a number of practice areas looking toward the future, too — for potential work.
The virtual designs that enable 3D printing — or additive manufacturing, as it’s often known in manufacturing circles — are based on a computer-aided design (CAD) file. That file is fed into a 3D printer that reads the two-dimensional image in the design and blends “layers” from the design to create a three-dimensional object.
The burgeoning technology promises to be a boon in a variety of manufacturing segments, but also an area to watch for lawyers. IP and patent attorneys will be asked by their clients to investigate infringement; product liability lawyers will have to defend a new range of claims; and even criminal lawyers might have to relearn what a weapon is, as 3D printing enables the manufacture of homebrew guns and other implements of mayhem.
But a lot of that is still in the future.
“There’s been surprisingly little patent litigation involving 3D printers,” said Ken Liebman, a partner and patent litigator with Faegre Baker Daniels who represents Stratasys, one of the largest 3D printer companies.
“We’re seeing rapid growth in the number of patents sought – not just by manufacturers, but also by companies in certain vertical industries such as medical devices,” said Liebman. “But most of the products are still in the development phase. I would guess that the significant patent litigation is still a few years out.”
Liability concerns ahead
Kim M. Schmid, executive managing partner at Bowman and Brooke, agrees that the legal issues around 3D printers are still developing — but they’re coming.
“The biggest thing our medical device clients wonder about the forecast for product liability litigation,” Schmid said. “There are definitely fewer answers than there are questions.”
Most of the few product liability cases around 3D printing are either pending or have been settled, meaning that case law in that area is nearly nonexistent. As more such cases are litigated, Schmid said, courts will eventually spell out the answers to a lot of questions.
“Who is the manufacturer of the product? Who is the seller? What is the product?” asks Schmid. “That’s what people really don’t know, is who’s liable: Is it the manufacturer of the 3D printer? The software designer? The surgeon in the O.R. who presses the button, or the hospital that owns the printer?”
Joseph M. Winebrenner, a Faegre partner who practices product liability defense, points out that the growing prevalence of startups will lead to more creative uses of 3D printing — along with more liability risks. Since product liability jurisprudence is based mostly on the idea that products are manufactured by a company that takes ownership of quality control, democratizing that manufacturing process down to the level of home hobbyists could complicate things.
“When you have individuals with access to 3D printers and open-source CAD files, there are major potential quality-control issues, and a blurring of the lines as to who the manufacturer is,” said Winebrenner. “Let’s say someone uses this technology to get a replacement part for a baby crib, it doesn’t work, and the resulting injury creates a liability issue. Who’s liable isn’t easily answered by traditional product liability law.”
While the courts haven’t begun dealing with 3D printers, regulators have. Earlier this month, the Food and Drug Administration issued draft guidance on technical considerations for additive manufactured devices in order to advise manufacturers who make devices via 3D printing techniques. The agency is also evaluating submissions for new 3D printed medical devices to determine their safety and effectiveness.
The draft guidance is meant to provide recommendations for device design, manufacturing, and testing considerations when developing 3D-printed devices. Manufacturers have until August to provide input, and then the FDA will publish final guidance on the regulatory implications.
“That draft guidance shows that this is something on the minds of regulatory agencies,” said Winebrenner.
One prediction about 3D printers that hasn’t yet come true involves the fear that they would engender a period of heedless counterfeiting of professionally manufactured products. Liebman said that 3D printers are unlikely to become the scourge that file sharing has been for producers of entertainment media.
“This isn’t like the PC industry, where anyone can quickly learn [how to infringe],” he said. “The printers themselves can be finicky, and the materials that get used have pluses and minuses.”
Regardless, lawyers in a number of fields are bracing for the first 3D printing-related case to be litigated, and for what the outcome might mean.
“It’s only been in the past 12 months that the FDA approved the first pharmaceutical product printed via 3D,” said Schmid. “We’re still in the infancy of how the courts will deal with this.”