Additive manufacturing, widely known as 3D printing, is a revolutionary leap forward in the world of manufacturing. It has the potential to impact all kinds of industries – from orthopedic implants, to jet turbines, to food. It’s also giving rise to the mass customization of consumer products.
With everyone from individuals to multi-national corporations getting in on this rapidly evolving field, there’s been a lot of talk about its impact on Intellectual Property.
But another issue is being largely ignored: What about liability? Hybrid CNC machines, designed to add metals 3D printing functions to other, more mature metrology and subtractive CNC milling technologies, are lighting up the manufacturing and maintenance worlds.
For anyone involved in (or thinking about getting involved in) 3D printing, it’s important to understand how we got to where we are today in terms of manufacturing liability, and what that means for this new space of additive manufacturing.
Patrick Comerford is Special Counsel in the Products Liability Group for the Boston law firm McCarter & English. He counsels manufacturers and retailers on product safety issues and risk management, and has defended high-profile clients in consumer product liability claims.
He’s also written about liability in additive manufacturing for legal and business journals. We spoke with Comerford to learn about the history – and future – of manufacturing liability, and what it means for those in the AM space.
Manufacturing liability through the centuries
“Up until the 19th century, everything was bespoke, meaning that everything was made by individual craftsmen: clothes, shoes, vehicles, tools, you name it,” says Comerford. “And if you got hurt using a product, you were pretty much on your own.”
After all, there were limited damages you could get from a one-man shoe shop. But with the rise of American industry around the 1920s, that began to change.
By mid-century, Comerford relates, manufacturers and retailers were being held liable for manufacturing errors and the problems they caused. As a result, we developed strict codes of liability and the extensive safety warnings we have today.
There are three primary legal reasons to sue for liability: if something went wrong in the manufacturing; if something was wrong with the design; or if the manufacturer did not adequately warn consumers about safety issues.
“Of those three reasons,” Comerford points out, “you almost never see a liability suit brought due to manufacturing error today.”
That’s because manufacturers have had years to get it right and establish the standards, he says, and as long as they follow those standards, they’re pretty safe.”
But with 3D printing, that could change, he adds: “With 3D printing, almost anyone can become a manufacturer. It’s an exciting time, but in some ways, it’s like going back to the 19th century, when a single individual made your tools or your carriage or your boat.”
Because standards have not yet been set, Comerford thinks it’s possible that we’ll see a recurrence of liability suits brought against this new class of manufacturers. After all, he points out, “Our society is a lot more litigious today than it was in 1899.”
Might new processes bring new lawsuits?
He makes the point that plaintiffs’ attorneys purposefully seek out new manufacturing processes, knowing they make good targets for liability claims.
Large corporations are using additive manufacturing to make parts for major industrial uses, like turbines, but they have the resources to laser scan their products and analyze them to ensure they meet standards.
But what about the little guys? Designers can also make products and sell them online. The question is, when the designer becomes the manufacturer, do they take on the manufacturer’s responsibility and liability? Comerford gives this example: “If you design a light switch and I buy it from you online, and then my house burns down, are you responsible? Are you the manufacturer?”
According to Comerford, we need to change the way we look at manufacturing quality and risk management, including consumer warnings, as the product channel shrinks and more control is given to the end user.
Retail giant Staples recently added 3D printing to its array of services. Customers can upload a design to the company’s website and have their item 3D printed, “more or less turning 3D printing into just another office supplies service, like copying, faxing, and 2D printing,” according to a press release from Staples.
So who is responsible in this case? “If someone were to manufacture something in the retail environment,” says Comerford, “the retailer would try to put all responsibility back on the designer. But if it went to court, the plaintiffs might come after the retailer. In this case, the retailer needs to specify their responsibility.”
Who’s a manufacturer? Depends on who you ask
“In the realm of 3D printing, it’s possible that everyone in the chain can be considered a manufacturer,” according to Comerford. “The designer, the CAD software maker, the 3D printer maker, even the maker of the filament.” In other words, we’re dealing with a whole new chain of distribution, which calls for new analysis of standards and rules.
As an example, Comerford points to a recent decision by the FDA regarding who was considered to be the “manufacturer” of health and medical applications built to run on mobile devices.
“The FDA chose to view every single player in the ecosystem as a manufacturer: the software company, the app owner, the programmer, even the people who update the software, entities who have little or nothing to do with the substance or functionality of the app,” says Comerford. Which means that a retailer might not get off so easy if a product printed in their store became the subject of a lawsuit.
Plan for the best and the worst
Additive manufacturing presents incredible potential, but it also presents some new challenges around ensuring product safety. It’s important to understand your responsibilities.
“It’s one thing if you’re manufacturing art pieces to sell online, and another if you’re developing a piece for a life-saving medical device, and yet another if you’re developing a mission-critical part for a jet engine,” Comerford notes.
Big corporations have the resources they need to thoroughly test and analyze their products. But smaller entities and individuals must still do what they can. If that applies to you, you should clarify roles and responsibilities from the get-go, make sure you understand what’s covered by your insurance policy and what isn’t, and do your best to make your processes and products as safe as you can.
“These aren’t issues that should keep anyone from getting into this space,” Comerford says. “But they are things that you need to consider to enhance your potential and protect yourself and your company.”
Patrick Comerford will be leading a panel discussion about the process, issues, and chain of commerce of additive manufacturing and 3D printing as part of Autodesk University in Las Vegas, Dec. 1-3, 2015. You can learn more about his session here or register for the event here.
Manufacturing liability, past, present, and future