3-D Printing

You Wouldn’t 3D Print Tylenol, Would You?

October 12, 2021
3-D Printing, Administrative Law, Bioethics, Biotechnology, FDA, Food and Drug Law, Health, Healthcare, Healthcare Reform, Medical Devices, Personalized Medicine, Pharmaceuticals, Uncategorized

By Mason Medeiros, MJLST Staffer

3D printing has the potential to change the medical field. As improvements are made to 3D printing systems and new uses are allocated, medical device manufacturers are using them to improve products and better provide for consumers. This is commonly seen through consumer use of 3D-printed prosthetic limbs and orthopedic implants. Many researchers are also using 3D printing technology to generate organs for transplant surgeries. By utilizing the technology, manufacturers can lower costs while making products tailored to the needs of the consumer. This concept can also be applied to the creation of drugs. By utilizing 3D printing, drug manufacturers and hospitals can generate medication that is tailored to the individual metabolic needs of the consumer, making the medicine safer and more effective. This potential, however, is limited by FDA regulations.

3D-printed drugs have the potential to make pill and tablet-based drugs safer and more effective for consumers. Currently, when a person picks up their prescription the drug comes in a set dose (for example, Tylenol tablets commonly come in doses of 325 or 500 mg per tablet). Because the pills come in these doses, it limits the amount that can be taken to multiples of these numbers. While this will create a safe and effective response in most people, what if your drug metabolism requires a different dose to create maximum effectiveness?

Drug metabolism is the process where drugs are chemically transformed into a substance that is easier to excrete from the body. This process primarily happens in the kidney and is influenced by various factors such as genetics, age, concurrent medications, and certain health conditions. The rate of drug metabolism can have a major impact on the safety and efficacy of drugs. If drugs are metabolized too slowly it can increase the risk of side effects, but if they are metabolized too quickly the drug will not be as effective. 3D printing the drugs can help minimize these problems by printing drugs with doses that match an individual’s metabolic needs, or by printing drugs in structures that affect the speed that the tablet dissolves. These individualized tablets could be printed at the pharmacy and provided straight to the consumer. However, doing so will force pharmacies and drug companies to deal with additional regulatory hurdles.

Pharmacies that 3D print drugs will be forced to comply with Current Good Manufacturing Procedures (CGMPs) as determined by the FDA. See 21 C.F.R. § 211 (2020). CGMPs are designed to ensure that drugs are manufactured safely to protect the health of consumers. Each pharmacy will need to ensure that the printers’ design conforms to the CGMPs, periodically test samples of the drugs for safety and efficacy, and conform to various other regulations. 21 C.F.R. § 211.65, 211.110 (2020). These additional safety precautions will place a larger strain on pharmacies and potentially harm the other services that they provide.

Additionally, the original drug developers will be financially burdened. When pharmacies 3D print the medication, they will become a new manufacturing location. Additionally, utilizing 3D printing technology will lead to a change in the manufacturing process. These changes will require the original drug developer to update their New Drug Application (NDA) that declared the product as safe and effective for use. Updating the NDA will be a costly process that will further be complicated by the vast number of new manufacturing locations that will be present. Because each pharmacy that decides to 3D print the medicine on-site will be a manufacturer, and because it is unlikely that all pharmacies will adopt 3D printing at the same time, drug developers will constantly need to update their NDA to ensure compliance with FDA regulations. Although these regulatory hurdles seem daunting, the FDA can take steps to mitigate the work needed by the pharmacies and manufacturers.

The FDA should implement a regulatory exception for pharmacies that 3D print drugs. The exemption should allow pharmacies to avoid some CGMPs for manufacturing and allow pharmacies to proceed without being registered as a manufacturer for each drug they are printing. One possibility is to categorize 3D-printed drugs as a type of compounded drug. This will allow pharmacies that 3D print drugs to act under section 503A of the Food Drug & Cosmetic Act. Under this section, the pharmacies would not need to comply with CGMPs or premarket approval requirements. The pharmacies, however, will need to comply with the section 503A requirements such as having the printing be performed by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician, limiting the interstate distribution of the drugs to 5%, only printing from bulk drugs manufactured by FDA licensed establishments and only printing drugs “based on the receipt of a valid prescription for an individualized patient”. Although this solution limits the situations where 3D prints drugs can be made, it will allow the pharmacies to avoid the additional time and cost that would otherwise be required while helping ensure the safety of the drugs.

This solution would be beneficial for the pharmacies wishing to 3D print drugs, but it comes with some drawbacks. One of the main drawbacks is that there is no adverse event reporting requirement under section 503A. This will likely make it harder to hold pharmacies accountable for dangerous mistakes. Another issue is that pharmacies registered as an outsourcing facility under section 503B of the FD&C Act will not be able to avoid conforming to CGMPs unless they withdraw their registration. This issue, however, could be solved by an additional exemption from CGMPs for 3D-printed drugs. Even with these drawbacks, including 3D-printed drugs under the definition of compounded drugs proposes a relatively simple way to ease the burden on pharmacies that wish to utilize this new technology.

3D printing drugs has the opportunity to change the medical drug industry. The 3D-printed drugs can be specialized for the individual needs of the patient, making them safer and more effective for each person. For this to occur, however, the FDA needs to create an exemption for these pharmacies by including 3D-printed drugs under the definition of compounded drugs.

Printing Pistols: Litigation Continues over the Legality of 3-D Printable Firearms

October 1, 2018
3-D Printing, Litigation

Holm Belsheim, MJLST Staffer

3-D printing is the process of creating three dimensional objects by layering very thin layers of plastic into the desired shape. All you need is the printer, raw material, and a good blueprint. From gadgets and toys for home use to replacement organs, there are many things one can make. Some of the possibilities, however, pose significant legal concerns. At the heart of years of litigation is a group behind the designs for a working, 3-D printable firearm.

In 2013 Cody Wilson founded Defense Distributed to distribute and monetize 3-D printable gun designs. Defense Distributed’s first design, the Liberator, could fire a single shot. Plans for the Liberator were downloaded an estimated 100,000 times from the Defense Distributed website alone, and have since been hosted on several other sites. As of 9/25/2018, a search of the Defense Distributed file site DEFCAD turned up nine different designs for printable guns and gun parts. The group ultimately hopes to create a larger community of 3-D gun designers and printers.

Ignoring the national debate over firearms, 3-D printed guns pose a unique security risk. Making a gun is not illegal. Liberators are concerning because, like most 3-D printed objects, they are made of plastic. They aren’t detectable by metal detectors, and furthermore lack serial numbers or other identifying information. Per the Undetectable Firearms Act, undetectable guns have been illegal since 1988. While the Liberator design incorporates two metal pieces, one solely to set off metal detectors, the design doesn’t require them to function. Anyone with a 3-D printer can choose whether to include these pieces. Thus, these ‘ghost guns’ pose a substantial security risk.

The Liberator debuted on May 6th, 2013. Two days later, Defense Distributed took down the designs after the U.S. State Department deemed them a violation of export laws under the Arms Export Control Act. In 2015, citing 1st, 2nd and 5th Amendment arguments, Defense Distributed sued the United States in District Court (Defense Distributed v. U.S. Dept.t of State, 121 F.Supp.3d 680, (W.D.T.X. 2015)) and then, upon appeal, in the Fifth Circuit (838 F.3d 451, (5th Cir. 2016)) before being denied certiorari by the U.S. Supreme Court. Surprising some, the U.S. Government settled with Defense Distributed in 2018, giving the group license to upload the plans again as well as paying some of their legal fees. Only a few days after the plans were reuploaded however, Oregon and several states sued Defense Distributed, the U.S. State Department and others.(State of Washingtonv. U.S. Dept.of State2:18-cv-01115-RSL (W.D.W.A. 2018)). Subsequently U.S. District Judge Robert Lasnik issued a restraining order against Defense Distributed’s hosting of the plans.

So far, the injunction doesn’t seem to have done much. Near the end of the order is this phrase: “Regulation under the AECA means that the files cannot be uploaded to the internet, but they can be emailed, mailed, securely transmitted, or otherwise published within the United States.” Interpreting this literally, Defense Distributed removed the option to directly access digital plans but has continued sales through other means, namely mailing copies on USB sticks. At least 400 orders have been placed. Whether this workaround remains legal will likely be brought up in the future. For now it’s anyone’s guess whether Defense Distributed read it correctly or played a little too loose with the spirit of the injunction. My prediction is that Defense Distributed won’t be penalized: the options laid out in the injunction are too specific to be accidental.

The litigation is expected to continue. As of 9/25/2018, Defense Distributed has raised $342,000 for its legal expenses while receiving assistance from the Second Amendment Foundation and others. Meanwhile, a total of 21 Attorneys General are on the opposing side. They cheered the injunction but aim for more, potentially a complete ban on 3-D printable guns. The arrest of former Defense Distributed director Cody Wilson on unrelated charges has had no effect upon the case so far.

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

February 12, 2017
3-D Printing, FDA, Product Liability

[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

October 31, 2016
3-D Printing, EU Law, New Technology, Public Safety, Regulatory

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

October 15, 2016
3-D Printing, Biotechnology, Food and Agriculture

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

February 17, 2016
3-D Printing, Food and Agriculture

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

December 2, 2015
3-D Printing, Medical Devices, Public Health

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/

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

December 2, 2015
3-D Printing, Medical Devices, Public Health

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/

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