3-D Printing Leaps Ahead of Product Liability Law

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By Alexis Kramer

Sept. 27 — The idea of printing three-dimensional objects—everything from robots to jet engine parts to human body parts—seems more like science fiction than reality.

The technology behind the 3-D printing phenomenon actually has been around since the 1980s, but the technique's popularity is exploding as more of the printers make their way into tech shops, schools and homes, allowing users to bring new ideas to fruition. Global revenue for the 3-D printing market is estimated to reach $35.4 billion in 2020, more than double the $15.9 billion forecast for this year, according to the International Data Corporation, a market research firm. Leading 3-D printer manufacturers include Stratasys Ltd., 3-D Systems Inc. and MakerBot Industries LLC, according to Bloomberg Intelligence.

As with any emerging technology, though, the law hasn't kept pace. Strict liability—one of three product liability theories which holds manufacturers liable for injuries caused by a defect, regardless of fault—may be difficult to apply in cases of 3-D printed products, given the uniqueness of the technology and the fact that numerous actors are involved in the production chain, product liability lawyers told Bloomberg BNA.

“There is no longer just one manufacturer and designer with this technology,” said James Beck, counsel at Reed Smith LLP in Philadelphia, whose practice includes product liability and 3-D printing.

The Food and Drug Administration in August 2015 approved the first-ever 3-D printed prescription drug: Aprecia Pharmaceuticals Co.'s SPRITAM, which treats epileptic seizures and rapidly disintegrates with a sip of liquid. General Electric Aviation plans to acquire two 3-D printer manufacturers, Arcam AB and SLM Solutions Group AG, for $1.4 billion and aims to build a $1 billion 3-D printing business by 2020. GE Aviation has introduced 3-D printed fuel nozzles for its LEAP jet engines into airline service and plans to print 40,000 of them by 2020.

Health-care and aerospace currently are the two main fields for 3-D printing, but the technology is making its way into several other industries, including automobiles, electronics and food.

The technique is booming despite the fact that it's unclear what product liability standard to apply to 3-D printed products. As more 3-D printed products are invented, courts eventually will have to tackle the question.

“3-D printing is a brand new technology, and caselaw is still evolving,” David L. Ferrera, a partner at Nutter McClennen & Fish LLP in Boston who chairs the firm's product liability and toxic tort litigation practice group, said.

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Although 3-D printers come in several different types, the basic process is the same. After creating or downloading a computer-aided design for a 3-D model, the design is uploaded to a printer, which then adds the desired material—one layer at a time—onto a “build tray” until the object is created. In 3-D printers such as the Makerbot, the print head moves around a horizontal plane, and the build tray moves down, once each layer is completed. The coding within a digital file supplies coordinates to the print head so it knows where to move as its nozzle extrudes the raw material to create the object.

Many Actors Involved

One complication in determining liability in 3-D printing is that a lot of people involved in the object's design or manufacturing could conceivably be responsible for a flaw that turns up in the finished product. Printer manufacturers or product makers might be responsible for defects, because of a problem with the printer's scanner or an issue with the raw material. Other actors potentially at fault in a liability case are: the digital file's designer; the 3-D printing service; or consumers who handled their own designing or printing.

The list of players in the process doesn't stop there. In the case of a medical devices, potential defendants could include hospitals or physicians, if they supply the 3-D printed devices. A pharmacist supplying a 3-D printed drug could also potentially be liable. Given the varied chain of players on the road to production, it's not clear whom a party injured by a 3-D printed product should try to hold liable.In addition to the long list of actors involved, the person actually responsible for the defect may not be readily identified.

One cornerstone of 3-D printing is that consumers can easily design and make the products they want. But it's not necessarily clear who the designer is, Beck said. Products based on digital designs can be uploaded anonymously to the cloud, so anyone can tweak them, he said.

Another major factor is that 3-D printing lets manufacturers create custom products that may be harder to make with traditional manufacturing methods. For example, orthopaedic manufacturers may be able to 3-D print prosthetic implants to custom fit a patient’s anatomy, said Robyn S. Maguire, a partner at Nutter and a member of the firm's product liability and toxic tort litigation practice group.

Such specificity has its benefits. But it creates another potential complication for liability—and ensuring the soundness of products—because manufacturing defects may be harder to detect when every 3-D printed object is slightly different, she said.

Up to the Courts

Product liability is generally governed by state law, but there are several basic legal theories that come into play, including negligence, breach of warranty and strict liability. A majority of states have enacted strict liability laws, which hold the manufacturer and supplier liable for products that are defective and unreasonably dangerous to users, regardless of fault. These laws may not fit well in the 3-D printing world, as it could hold 3-D printer manufacturers liable for a host of inventions that were not intended for their machines.

Beck said a 3-D printer manufacturer couldn't possibly foresee all the potential injuries that could be caused by one of the seemingly endless types of products that could be created with that printer. So the printer manufacturer would likely not be held liable, he said.

It is also unlikely that a manufacturer would be held strictly liable for a defect in a digital file, Beck said. Those bringing lawsuits would undoubtedly seek to hold non-manufacturers in the production chain, who might be responsible for the injury, liable under a negligence theory.

Some attorneys disagree that a 3-D printer manufacturer couldn't reasonably expect to be held liable for products created from its printer.

William Cass, a partner at Cantor Colburn LLP in Hartford, Conn. who co-chairs the firm's Additive Manufacturing practice group, said he “could foresee a 3-D printer manufacturer being held accountable, especially if it knows that its machine is going to be used to make a particular product and/or has provided guidance as to the set up and operation of the machine to make the part.”

Martin Galese, general counsel at Formlabs Inc., a Massachusetts-based 3-D printer manufacturing company, said a 3-D printer is a tool for creating products, comparable, for example, to a drill. Printer makers should be subject to the same level of liability that a drill manufacturer would be if a defective object was made with their drill, he said.

“I hope that courts would look at the 3-D printer manufacturer as they would look to a company that made a power tool,” Galese said.

Galese said applying product liability law to 3-D printing services and marketplaces, such as Shapeways, will be a challenge because they are using the 3-D printer to create products based on designs from third parties.

Ira M. Schwartz, a partner at Parker Schwartz PLLC in Phoenix whose practice includes 3-D printing issues, said that generally in product liability law, a person not regularly in the business of manufacturing and selling a particular product won't be considered a manufacturer for purposes of finding strict liability. Applying this principle to the 3-D printing context, home hobbyists and 3-D printing businesses that make one type of object one day and another the next may not have strict liability if they sell a defective product, Schwartz said. They could be held liable if they negligently manufactured the product, but negligence is a higher standard than strict liability and harder to prove, he said.

An argument could be made that a business that creates and sells 3-D printed objects should be liable for whatever product they create, but the proper standard will depend on the facts of the first cases to get litigated, Schwartz said.

3-D Printing Companies Inform Users

Amidst the hazy legal climate, 3-D printer makers and printing services are taking steps to minimize the risks of product defects and injuries.

Shapeways' terms of service provides a warranty that the model it manufactures “will substantially meet the features of the indicated 3-D Model within the limitations of the 3-D printing technology.” It provides that the user is legally responsible for the design specifications and performance of the created object.

The terms also state—in bold font—that the materials Shapeways uses to make the 3-D models are suitable for decorative purposes only. It warns customers that the models shouldn't come in contact with electricity and should be kept away from heat.

Galese of Formlabs said that to avoid product defects, 3-D printer users need to understand the properties of the raw materials chosen to create their products.

In April, Formlabs introduced Dental SG Resin, a biocompatible resin designed primarily for medical professionals to 3-D print dental surgical guides. The company provides guidance and instructions for the material's use on its website, including on how to prepare the design file for the printer and post-processing.

“We encourage people to use the right material in the right way,” Galese said.

But even when all the parties in the process are doing all they can to avoid problems, 3-D printing carries risks—especially as guidance and case law on the technology continues to evolve, Ferrera said. “You have to continue forward and go on with your business,” he said.

Ultimately, the uncertain legal terrain for 3-D printing is similar to any innovative and growing technology.

“That’s what happens when you have leading-edge technology,” Schwartz said. “You just can never be certain about how the law will apply to that technology, until the first few cases get litigated.”

To contact the reporter on this story: Alexis Kramer in Washington at akramer@bna.com

To contact the editor responsible for this story: Keith Perine at kperine@bna.com

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