3-D Printing

3D Printing: What Could Happen to Products Liability When Users (And Everyone Else in Between) Become Manufacturers?

[Editor’s Note: Invited Bloggers James Beck & Matthew Jacobson co-authored the article on 3D printing in MJLST’s recent issue. This post summarizes the main arguments of their analysis.]

3D printing has the potential to disrupt and transform not only how and where objects are made, but all aspects of the law, including products liability.  In their recent article, 3D Printing: What Could Happen to Products Liability When Users (And Everyone Else in Between) Become Manufacturers (18 Minn. J.L. Sci. & Tech. 145), James Beck and Matthew Jacobson explore the legal implications 3D printing may have on product liability common-law and how courts, legislatures, and regulatory agencies may act in the wake of this novel technology.  The first part of this comprehensive guide covers what is 3D printing and how this new technology works, an overview of traditional tort liability concepts, and the gray area that forms when the two meet.  The second part of the article focuses on 3D printing’s impact on medical devices and health care and the product liability considerations that are specific to these highly technical and potentially life-saving products.

Given that 3D printing appears to be the next greatest chapter in the industrial revolution, with the technology often moving more rapidly than the law, this article is significant in that it comprehensively analyzes the current state of products liability law and the legal issues affecting this body of law arising from the 3D printing of products.

As the article explains, 3D printing is already starting to revolutionize different industries, including automotive, aerospace, and healthcare.   Individuals can already “print” products from a store (online or brick-and mortar) and their own homes (assuming they have a 3D printer and the necessary software and supplies).  In the future, airplane parts may be able to be printed from airports, car parts at a mechanic’s shop, and medical devices at a hospital or doctor’s office.  As the technology develops, the question becomes will the law also develop, especially as people get injured by these 3D printed products and the processes in by which they are printed.

Products liability is a relatively new area of the common law—although not as new as 3D printing—beginning its development in the 1960s, when manufacturing transitioned from local artisans and workshops to assembly-line processes.  Now that 3D printing may once again change the traditional way in which we view manufacturing, the law may also have to change once again.  Because strict products liability focuses on where products are manufactured and who designs and manufacturers those products, it may not be suited to address how and where 3D printed products are made.  These issues include what is a “product,” who is a “manufacturer,” what is the “marketplace,” and who has a duty to warn.  Each of these questions raises numerous issues, which will need to be addressed as courts are faced with the potential inadequacies in the common-law.  3D printing manufacturing techniques may also increase the number of possible products and manufacturers (once those terms are defined), so there are more scenarios of who may be liable then with traditional manufacturing techniques, which will result in courts and juries being left to sort it all out.

Beck and Jacobson discuss these issues and the current state of the common-law in depth, which includes analysis of product liability court opinions with respect to 3D printing (so far minimal) and comparable (to the extent possible) products and technologies.  While it is still uncertain how products liability law will develop or change, what is certain is that the law will change, and the authors offer their take on the changes that may come.

The potential issues 3D printing may have on products liability law only becomes more multifaceted, as the 3D printed products become more complex and technical, such as medical devices and pharmaceutical drugs and production shifts from central facilities to hospitals/doctors’ offices.  As the article explains, 3D printing has perhaps the greatest potential to benefit human lives and health care, even if the exact nature of those developments are hard to predict.  But with that great potential comes legal uncertainty, especially since medical devices and drugs are regulated in the United States by the Food and Drug Administration (“FDA”).

One of the legal challenges explored in article is the FDA regulatory framework for 3D printed medical devices.  The FDA currently views 3D printing as another form of advanced manufacturing, and thereby fits this technology in its already existing framework.  The FDA has already cleared (through its “510(k)” process) approximately 85 medical devices and approved one drug manufactured through 3D printing technology.  However, manufacturing truly innovative medical devices—such as bio-printed devices, medical devices made using a patient’s own stem cells—through 3D printing will require more FDA guidance.  As the article discusses, 3D printing is on the FDA’s agenda and the agency is continuing to better understand this technology and its place in improving healthcare.

The article not only points out the unknown product liability issues that may result from 3D printing, but also offers strategic insights, which may be useful to mitigate risk or to develop the common-law.  The article is a necessary guide for anyone involved in the 3D printing process, including manufactures of 3D printed products, manufactures of the printers, the computer software designers, the manufactures of 3D printing scanners, sellers of 3D printed products (all possible product liability defendants in the future), and even consumers or users of these products.

While the article focuses primarily on tort liability, the authors and their colleagues have published two white papers on similar issues, as well as other key legal issues including intellectual property, constitutional law, commercial litigation, data privacy, environmental effects, health risks in the workplace, and insurance risks and recovery:  3D Printing of Medical Devices:  When a Novel Technology Meets Traditional Legal Principles and 3D Printing of Manufactured Goods: An Updated Analysis.  The article, along with the two white papers, provide a wide-ranging guide on the legal implications of this novel technology across different practice areas.


Permissionless Innovation or Precautionary Principle: The Policy Menu of the Future

Ethan Konschuh, MJLST Staffer

In their recent paper, Guns, Limbs, and Toys: What Future for 3D Printing?, published in the Minnesota Journal of Law, Science, and Technology Volume 17, Issue 2, Adam Thierer and Adam Marcus discussed the potential regulatory frameworks for technological innovations that could spur what they call “the next great industrial revolution.”  They believe that 3D printing, one such innovation, could offer such great benefits that it could significantly enhance global welfare.  However, they worry that preemptive regulations on the technology could undermine these benefits before giving them a chance to be realized.  The paper advocates for a method of regulation called “permissionless innovation,” as opposed to regulations following the “precautionary principle.”  While there are many pros to the former, it could leave unchecked the risks curtailed by the latter.

“Permissionless innovation refers to the notion that experimentation with new technologies and business models should generally be permitted by default.”  It follows from the idea that unless a compelling case can be made that a new invention will bring serious harm to society, innovation should be allowed to continue unabated, and problems, should they arise, can be addressed later.  The authors point to numerous benefits of this approach with respect to emerging technologies.  One of the most obvious benefits is that this type of regulatory framework does not prematurely inhibit potential benefits.  “Regulatory systems based on precautionary thinking focus on preemptive remedies that aim to predict the future and its hypothetical problems. But if public policy is rooted in fear of hypothetical worst-case scenarios, it means that best-case scenarios will never come about.”  It would also preserve the modern startup culture where “just about anyone can afford to launch a business.”  Implementing a framework based on the precautionary principle will create barriers to entry and raise the cost of innovation.  This would also reduce the ability to maximize competitive advantage through trial and error, which refines the technology and efficient allocation of resources for development.  As an example of the potential detriments to competitive advantage from preemptive regulation, the authors point to the different policies of the Europe and the U.S. in the mid-nineties internet explosion where the former preemptively regulated and the latter allowed for permissionless innovation, resulting in the U.S. being a global leader in information technologies and Europe lagging far behind.

An alternative regulatory approach discussed in the article is based on the precautionary principle, which generally refers to the belief that new innovations should be curtailed or disallowed until it can be proven that they will not cause harm.  This approach, while posing problems of its own discussed above, would solve some of the problems arising under permissionless innovation.  While there are many economic and social benefits to permissionless innovation as the bedrock on which policy rests, it inherently allows for the “error” half of “trial and error.”  The whole concept is rooted in the idea of ex post regulation, creating policy to correct for problems that have already occurred.  While traditionally, as shown through the internet regulation difference and outcome between Europe and the U.S., the risk of error has not outweighed the benefits that result, new technologies pose new risks.

For example, in the realm of 3D printing, one of the hot topics is 3D printed firearms.  Current laws would not make 3D printed guns illegal, as most regulations focus on the sale and distribution of firearms, not creation for personal use.  The reasons why it might be more prudent to adopt a precautionary principle approach to regulating this technology are obvious.  To adopt an ex post approach to something that could have such dire consequences could be disastrous, especially considering the amount of time required to adopt policy and implement regulations.  Permissionless innovation could thus become a sort of self-fulfilling prophecy in that major tragedies resulting from 3D printing could result in exactly what advocates of permissionless innovation seek to prevent in the first place: strict regulation that undermines the development of the technology.

The debate will likely heat up as technology continues to develop.  In the era of self-driving cars, private drones, big data, and other technologies that continue to change the way that humans interact with the world around them, 3D printing is not the only area in which this discussion will arise.  The policy decisions that will be made in the next few years will have far reaching consequences that are difficult to predict.  Do the economic and social benefits of being able to manufacture goods at home outweigh the risks of legal, discrete self-armament and its consequences?  The proverbial pill may be too large for some to swallow.


Food “Hot Off the Printing Press”: Insights into 3-D Printed Food

Theodore Harrington, MJLST Managing Editor

Would you food hot off the 3D printing press? In Jaspers Tran’s article, 3-D Printed Food, he explores the potential legal issues surrounding the commercialization of 3D printed food. (see here).

The article suggests that “. . . the 3D printer may become the fundamental daily appliance in every household . . . .” The pros are easy to see—As the demand for food increases at an exponential rate, the ability to create food quickly and avoid the current environmental impacts caused by food production would be a game-changer. The benefits here are fairly obvious and easy to wrap our heads around. However, large barriers still remain.

A tougher point for me to grasp is Tran’s suggestion that 3D printing will solve issues related to malnutrition, particularly over-nutrition, or obesity. Tran seems to leap from personalized nutritional food (tailored to an individual’s exact nutritional needs) to an obesity solution. This reminds me of the old adage, “you can lead a horse to water, but you can’t make him drink.”

Even if 3D printers end up in every household, my gut-feeling is that it will be a very long time before people are accepting of the idea of eating food that was just spit out of a machine (although there is a large amount of processing in today’s food, it goes on behind closed doors. Ignorance is bliss.). As Malcolm Gladwell suggests in his book Blink, the way we taste food is as much psychological as it is physical (see example of declining sales in a pork product when a life-like pig was placed on packaging instead of a cartoon pig).

Something to chew on.


3D Food Printing and Its Legal Complications

Riley Conlin, MJLST Staffer

According to a recent article in Bloomberg, the FDA has recently approved the use of a drug that was 3D printed for the first time. The first drug the FDA approved is Spritam, which was created by Aprecia Pharmaceuticals. The drug is to be administered orally to treat adults and children for epilepsy. The 3D printing process supposedly allows the pill to dissolved quickly, which means it will enable the pill to act faster in the case of an oncoming seizure. When this approval occurred several attorneys voiced concern, because of the intellectual property issues related to 3D printing. First, it would be difficult to determine the manufacturer of the drug, making the assignment of IP rights quite challenging. Second, because it would be difficult to determine the manufacturer, it would also be difficult to identify liable parties in potential litigation.

While there are undoubtedly legal issues related to 3D printing, a forthcoming article in the Minnesota Journal of Law Science and Technology Symposium argues that the benefits far outweigh potential legal issues that could slow the adoption of 3D technology in the area of food production. Symposium author, Jasper Tran, notes that there are “endless possibilities” associated with 3D food printing. First, the ability to print food has the potential to significantly impact the global food shortage crisis, because healthy food can be mass-produced via 3D printers. He also argues that 3D printing has the potential to reduce environmental harms associated with current food production. However, he does note that there are legal liability issues with 3D printing, including (1) short-term food poisoning on an individual scale or mass scale and (2) long term impacts of food printing. Despite these concerns, Tran argues the legal risks are far outweighed by the potential global benefits of mass-producing food via 3D printers.

As discussed in the Bloomberg article and in Tran’s note, 3D food and drug printing is the future. It is the responsibility of government organizations to take a proactive approach and attempt to enact rules and regulations that anticipate the new legal issues and challenges associated with the process.


Disruptive Manufacturing is Disrupting the Law: Minnesota Journal of Law, Science & Technology Presents a Symposium on the Rapid Emergence of 3-D Printing and Its Legal Implications

Nia Chung, MJLST Symposium Editor

Imagine your six-week old newborn suddenly stops breathing. You rush him to the hospital, where he is diagnosed with tracheobronchomalacia, which means that his windpipe has collapsed. Your doctor tells you that she can provide the conventional treatment of conducting a tracheostomy and putting your newborn on a ventilator which might lead to further breathing problems and possible heart stoppage. She goes on to tell you that she can 3-D print a device that will instantly help your newborn breathe, and she does. This is a true story. Kaiba Gionfriddo, who was treated at C.S. Mott Children’s Hospital through a groundbreaking cross-disciplinary effort between the University of Michigan’s Medical and Engineering schools, doctors, faculty, and researchers in 2011, was the first patient ever to experience a surgery of its kind. Kaiba’s story was just the beginning of medical and surgical breakthroughs using 3-D printing.

But what exactly is 3-D printing? 3-D printing, also called additive manufacturing, is the process of making solid three-dimensional objects from a CAD (Computer Aided Design) digital file. Based on this digital file, 3-D modeling software “slices” the three dimensional model “into hundreds or thousands of horizontal layers. The sliced file is then uploaded to a 3-D printer, which creates the 3-D object. There are several technologies 3-D printer manufacturers can utilize to generate 3-D objects—some use melting or softening material in a technology called “selective laser sintering” or “fused deposition modeling” and others cure a photo-reactive resin with a UV laser. A small, low-quality object can be printed in less than 10 minutes, while larger, high-quality objects may take up to several hours to print. By and large, 3-D printers are cost-effective, efficient, and can provide insurmountable benefits to the healthcare industry.

Baby Kaiba and his biodegradable splint showed the world how 3-D printing can be used in healthcare. Researchers have taken it further by bioprinting trachea, grown using a patient’s own stem cell cultures. This would essentially be the “first artificial bioprinted organ,” and doctors are hoping for Food and Drug Administration (FDA) approval. What the FDA has approved recently, however, is the first ever 3-D printed drug product. In August 2015, the FDA approved Aprecia Pharmaceutical’s Spritam (levetiracetam). A drug product used orally to treat “partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy.” Other examples of how 3-D printing is transforming healthcare include 3-D printed blood vessels, heart valves, low-cost prosthetics designed specifically to a patient’s anatomy, and electronic sensors that monitor heart strain, oxygenation, and temperature that can be perfectly attached to a patient’s heart.

Although additive manufacturing is cost effective, waste-reducing, and efficient, it presents legal challenges in areas ranging from intellectual property to product liability. A white paper published by Reed Smith outlines the impact 3-D printing will have on areas including regulatory issues, patent and copyright law, tort liability, and insurance. For example, what is a “product”? Is it the CAD digital file, the 3-D printed product, or both? Who is the manufacturer? Is it CAD or is it the 3-D printer? If I am in need of a replacement hip, and agree to have a 3-D printed hip implanted into my body, if that product is defective, who is liable—the hospital that performed the hip replacement surgery, the 3-D printer manufacturer, or the 3-D imaging software? From an intellectual property law standpoint, 3-D printing can provide easier access to counterfeit products, and can blur the line on what constitutes patent infringement. If a hospital 3-D prints repairs a medical device by 3-D printing a nonpatented replacement component, this would likely be lawful. On the other hand, “replicating replicating a patented device by using a 3D printer to create all of its components may well constitute patent infringement.” Because 3-D printing brings, along with its benefits, many unanswered questions in the law, the Minnesota Journal of Law, Science & Technology (MJLST) will be hosting a symposium on these very issues. It will feature experts on intellectual property, regulatory, and tort liability issues surrounding 3-D printing in an all day event. The symposium will consist of several panels and a keynote speech by Candice Ciresi, General Counsel of Stratasys, a leading 3-D printer manufacturer, along with breakfast and lunch. MJLST Volume 17.2, its symposium issue, will publish articles on issues covered at the live symposium.

Today, medical devices, body parts, pharmaceutical drugs, guns, and food can be 3-D printed in a matter of hours to be utilized by private citizens. Please join us at the symposium to hear from some of the nation’s experts on how we must regulate this technology moving forward and what we can expect from 3-D printing in the near future.

Minnesota Journal of Law, Science & Technology presents “A Symposium on Disruptive Manufacturing: The Rapid Emergence of 3-D Printing and Arising Legal Concerns.” The symposium will be held on March 4, 2016 at Walter F. Mondale Hall, The University of Minnesota Law School, 229 19th Ave. South, Room 25, Minneapolis, MN 55455, from 8:00 A.M. to 3:00 P.M. To attend the symposium or for more information, please e-mail chung439@umn.edu or visit the symposium’s website at https://sites.google.com/a/umn.edu/mjlst-symposium-2016-3-d-printing/home. Please visit and RSVP on our Facebook page: https://www.facebook.com/events/1651569518452959/