By now, most of us in the manufacturing world are familiar with the steady stream of news describing organizations, large and small, providing medical equipment using 3D printers. Face masks, face shields, swabs, and parts for ventilators are the most common—and needed—as the frontline medical community struggles to heal patients while protecting themselves. What could be simpler than to create a design, prep the data, ship it to a printer and send the finished part to a happy user or manufacturer?
It is not as simple as it sounds.
“There are literally hundreds of 3D printing designs to support the current COVID-19 response. Some work, others don’t. Some look great but do not work,” explained Dr. Jenny Chen, M.D., founder and CEO of 3DHEALS, a company focusing on education and industrial research in bioprinting, regenerative medicine, and healthcare applications using 3D printing. She was a moderator for a webinar panel titled “3D Printing Design for COVID-19,” presented April 22.
In their recently published paper, ‘What Shall we do with the Drunken Sailor? Product Safety in the Aftermath of 3D Printing,’ Klaus Heine and Shu Li discuss how a disruptive technology like 3D printing can also upset other more peripheral areas such as legal issues and product liability. Safety mechanisms must be in place to protect the public, and the authors question why there is not more concern over potentially ‘harmful 3D printed products,’ with an analysis of why ‘incumbent product liability law does not incentivize optimal deterrence.’
Focusing on the many novel 3D printing startups and business models associated with 3D printing as the ‘trigger,’ the authors point out how little informational content regarding ‘specific producers’ is provided.
James Beck is the senior life sciences policy analyst at Reed Smith. James is specialized in product liability, personal injury, especially in very large and very complex cases. Active in law for over thirty years he has been involved in cases U.S. District Court for the Eastern District of Pennsylvania, the U.S. Court of Appeals, Third Circuit and the Supreme Court. He is involved in mass torts, many amicus curiae briefs he is an award-winning expert in his chosen fields who writes often about the law. Over the past few years, James has taken an active interest in 3D Printing, especially with regards to product liability. He is part of Reed Smith’s 3D Printing team who take an active interest in all things printed. Reed Smith itself is a 1500 lawyer law firm with 28 offices around the world and over a billion dollars in revenue. It is both nice and significant when people like that take an active interest in our industry and technology. We interviewed James to find out more about 3D printing and the law, specifically product liability.
If a group of people was asked about the legal concerns associated with 3D printing, most would likely mention 3D printed guns. But the moral and legal debate the technology raises is much broader
If a group of people was asked about the legal concerns associated with additive manufacturing, also known as 3D printing, most would likely mention 3D printed guns. More specifically, the fear that nefarious individuals will print undetectable firearms in the privacy of their own home for nefarious purposes. In fact, as recently as this past summer, a U.S. Senator introduced draft legislation to prevent just such an occurrence by criminalizing attempts to proliferate the software blueprints for guns.
3D printing is not a young technology per se. The basic technology has been around for decades, but it has experienced a resurgence of innovation over the past couple of years. There are many different methods for 3D printing, but most involve the use of computer-aided design software (CAD) to instruct a digital fabricating machine that extrudes materials, via a layering pattern, to form objects. The technology is relatively unlimited in the materials it can print with, and in the complexity or size of the objects. 3D printers range broadly in cost and use from the industrial to home-based, and even to child-oriented devices. Notably, 3D printing is likely seeing this resurgence because of the expiration of foundational patents in the field that previously prevented too much innovation.
According to product liability law in the European Union, producers of products are subject to strict liability if products are defective and this leads to violations of certain legal interests (life, body, health, privately used objects). Persons other than producers are only liable under additional conditions.
“Producer” is therefore a key term in product liability law. If products are manufactured using 3D printing, the roles existing in the conventional value chain (supplier-producer-dealer-user) may change. Wholesalers and retailers may not be part of it, but other players may be added, such as the creator of the CAD file that contains the individual commands for controlling the 3D printer, and the person printing out the end product (a private or commercial user or an additional service provider). Product liability law – this applies to Germany, but equally to all other EU Member States – is based on the conventional value chain, however, and contains provisions which, unmodified, do not take account of these changed roles. For reasons of correctly offering incentives (those who are able to prevent or minimize risks should be given incentives to do so, within economic reason), but also for considerations of fairness, a broad interpretation of the term “producer” is therefore advisable. On the other hand, it seems appropriate to limit the liability of the persons so included to areas that they are controlling.
Germany is developing a distinct competitive edge in this emerging technology. But the realisation phase of this new tech’s life cycle has brought with it many questions concerning product liability and more.
From spare parts for the automotive sector to aircraft components and consumer goods, 3D printing technology can be produced quickly and inexpensively, with the added benefit that items can be more easily personalised.
German chemical giant BASF is among those taking significant strides in additive manufacturing and is collaborating with a growing network of organisations in an effort to take the applications of 3D printing beyond the prototype phase.
When the first 3D printed gun was fired in 2013, the blueprints were posted online for anyone to access. They were immediately taken down by order of the US government, but not before they had been downloaded nearly 100,000 times.
On August 1, plans for printable guns were allowed to be posted online once again. But attorneys-general in eight states, plus the District of Columbia, filed suits in an attempt to ban them. The court battle continues.
Additive manufacturing, or 3D printing, is the production of an object using a digital blueprint. The latest 3D printers can fit on a desk and cost less than $1,000. So long as you can find the right design and materials, you can make previously off-limit objects in your own home.
The relationship between 3D printing, copyright, and the protection of intellectual property has experienced some strain due to its necessarily digital nature. Readers may remember a debacle surrounding the unauthorized sale of 3D printed designs by Louise Driggers (aka Loubie) – an issue that was quickly cleared up thanks to the online community.
However, today in Brussels members of JURI, the European Parliament’s Committee on Legal Affairs, met to discuss intellectual property (IP) rights and civil liability of 3D printing.
In session with Conservative, Liberal and Green Party members Joëlle Bergeron, a member of the Eurosceptic Europe of Freedom and Direct Democracy group and former member of France’s National Front, presented an own-initiative report proposing legislative action to control and monitor additive manufacturing activity.
Technology’s influence on the insurance industry continues to grow in the age of digitalization. As the industry continues to infuse technology into its practice, it is increasingly susceptible to technological liabilities, such as increasing cyber and product liabilities and recall risks.
Business models in the digital economy are more complex and without clear borders, making liability harder to apportion and claims more complex to settle — despite the frequency of claims expected to decline. The growing “sharing economy” raises new questions about liability. In the future, a road traffic accident could involve the vehicle manufacturer, software provider, and the fleet operator, as well as third parties involved in the accident.
If you’re interested in the intersection of 3D printing and medical technology and happen to be near San Francisco, CA, next week, you might want to carve out some time to attend the 3DHEALS 2017 Global Conference: 3D Print Life. 3D HEALS is dedicated to the proposition that great things can happen if you bring together technologists from the start-up culture of Silicon Valley and the Bay Area and healthcare stakeholders under one roof.
The organization has been around for a couple of years and has produced five successful events during that time. By reaching out to various stakeholders in the healthcare system, technology, regulatory affairs and more, “it made us realize that it takes a village to make revolution happen, and many challenges can only be overcome by a well-organized ecosystem,” write event organizers on the website. “We are hoping that by organizing this global event, 3DHEALS will contribute to fostering this burgeoning yet still fragile ecosystem.”