Requiring Backdoors Into Encrypted Cellphones

January 20, 2016
Constitutional Law, Cyber Security, Data, First Amendment, Privacy

Steven Groschen, MJLST Managing Editor

The New York State Senate is considering a bill that requires manufacturers and operating system designers to create backdoors into encrypted cellphones. Under the current draft, failure to comply with the law would result in a $2,500 fine, per offending device. This bill highlights the larger national debate concerning privacy rights and encryption.

In November of 2015, the Manhattan District Attorney’s Office (MDAO) published a report advocating for a federal statute requiring backdoors into encrypted devices. One of MDAO’s primary reasons in support of the statute is the lack of alternatives available to law enforcement for accessing encrypted devices. The MDAO notes that traditional investigative techniques have largely been ineffective. Additionally, the MDAO argues that certain types of data residing on encrypted devices often cannot be found elsewhere, such as on a cloud service. Naturally, the inaccessibility of this data is a significant hindrance to law enforcement. The report offers an excellent summary of the law enforcement perspective; however, as with all debates, there is another perspective.

The American Civil Liberties Union (ACLU) has stated it opposes using warrants to force device manufacturers to unlock their customers’ encrypted devices. A recent ACLU blog post presented arguments against this practice. First, the ACLU argued that the government should not require “extraordinary assistance from a third party that does not actually possess the information.” The ACLU perceives these warrants as conscripting Apple (and other manufacturers) to conduct surveillance on behalf of the government. Second, the ACLU argued using search warrants bypasses a “vigorous public debate” regarding the appropriateness of the government having backdoors into cellphones. Presumably, the ACLU is less opposed to laws such as that proposed in the New York Senate, because that process involves an open public debate rather than warrants.

Irrespective of whether the New York Senate bill passes, the debate over government access to its citizens’ encrypted devices is sure to continue. Citizens will have to balance public safety considerations against individual privacy rights—a tradeoff as old as government itself.

Patent Damages

January 20, 2016
Competition, Intellectual Property, Patents

Tianxiang (Max) Zhou, MJLST Staffer

In Dec. 2015, almost five years after Apple sued Samsung for infringing a smartphone design patent, Samsung agrees to pay Apple $548 million. Apple is now demanding Samsung pay an additional $180 million for the patent dispute. Besides the huge amounts of damages, the case is not over and it continues raising fundamental issues of how to evaluate values of design patent infringements.

In the petition for writ of certiorari challenging the $400 million that it has paid for infringing Apple’s design patent, Samsung writes, “The questions presented are: . . . Where a design patent is applied to only a component of a product, should an award of infringer’s profits be limited to those profits attributable to the component?”

The second issue stated in the writ is noteworthy. Under the current rule, the awards in a design patent infringement case to the patent owner are the whole profits from the sale of the infringing products. This rule has created and will create massive jury verdicts in design patent infringement cases, and the Supreme Court has not reviewed the rule. As Samsung writes in the petition, “the Supreme Court has not reviewed a design-patent case in more than 120 years.” With the new development of the industries and various design patents, it is doubted whether the awards of whole profits are reasonable.

Although statistically the Supreme Court will not take the case, the issue of design patent awards raised heated discussions. In 2014, a group of 27 law professors submitted an amicus brief in support of Samsung urging the Federal Circuit to interpret the relevant statutory provision to limit the award of profits in design patent infringement cases. The amicus brief stated: “the Court should require proof of some connection between the patented design and the defendant’s profits, the order the district court to remit the award of profits to the extent it exceeds those profits attributable to the patented designs.” The professors argued the origin and context of the controlling statute Section 289, and that awarding a defendant’s entire profits makes no sense in the modern world, and to prevent disgorgement of profits.

As stated above, the Supreme Court has not reviewed the issue for over one hundred years. With the unsettled dispute between Samsung and Apple continuing, we could look forward to whether the Supreme Court would take the case and redefine Section 289. However, a question posed to the judges is, if the awards to the design patent infringement are not the whole profits of the sale, then what proportion of the profits should be awarded? Judges should figure out a reasonable standard to evaluate the amount attribute to the infringed design.

Recent Developments in Automated Vehicles Suggest Broad Effects on Urban Life

January 20, 2016
Autonomous Vehicles, Business Law, Competition, Intellectual Property

J. Adam Sorenson, MJLST Staffer

In “Climbing Mount Next: The Effects of Autonomous Vehicles on Society” from Volume 16, Issue 2 of the Minnesota Journal of Law, Science & Technology, David Levinson discusses the then current state of automated vehicles and what effects they will have on society in the near and distant future. Levinson evaluates the effect of driverless cars in numerous ways, including the capacity and vehicles-as-a-service (VaaS). Both of these changes are illuminated slightly by a recent announcement by Tesla Motors, a large player in the autonomous vehicle arena.

This week Tesla announced Summon which allows a user to summon their tesla using their phone. As of now, this technology can only be used to summon your car to the end of your drive way and to put it away for the night. Tesla sees a future where this technology can be used to summon your vehicle from anywhere in the city or even in the country. This future technology, or something very similar to it, would play a pivotal role in providing urban areas with VaaS. VaaS would essentially be a taxi service without drivers, allowing for “cloud commuting” which would require fewer vehicles overall for a given area. Ford has also announced what it calls FordPass, which is designed to be used with human-driven cars, but allows for leasing a car among a group of individuals and sharing the vehicle. This technology could easily be transferred to the world of autonomous vehicles and could be expanded to include entire cities and multiple cars.

Beyond VaaS, these new developments bring us closer to the benefits to capacity Levinson mentions in his article. Levinson mentions the benefits to traffic congestion and bottlenecks which could be alleviated by accurate and safe autonomous vehicles. Driverless vehicles would allow for narrower lanes, higher speed limits, and less space between cars on the highway, but Levinson concedes that these cars still need to “go somewhere, so auto-mobility still requires some capacity on city streets as well as freeways, but ubiquitous adoption of autonomous vehicles would save space on parking, and lane width everywhere.” Tesla is seeking to alleviate some of these issues by allowing a vehicle to be summoned from a further distance, alleviating some parking congestion.

Audi, however, is seeking to tackle the problem in a slightly different fashion. Audi is partnering with Boston suburb Somerville to develop a network including self-parking cars. “UCLA urban planning professor Donald Shoup found 30 percent of the traffic in a downtown area is simply people looking for parking” and eliminating this traffic would allow for much higher capacity in these areas. Similarly, these cars will not have people getting in and out of them, allowing for much more compact parking areas and much higher capacity for parking. Audi and Tesla are just some of the companies working to be at the forefront of automated vehicle technology, but there is no denying that whoever the developments are coming from, the effects and changes David Levinson identified are coming, and they’re here to stay.

General Motor’s $500 Million Investment in Lyft: A Reminder to State Legislatures to Quickly Act to Resolve Legal Issues Surrounding Self-Driving Cars

January 20, 2016
Autonomous Vehicles, Business Law, Competition

Emily Harrison, MJLST Editor-in-Chief

On January 4, 2016, General Motors’ (G.M.) invested $500 million in Lyft, a privately held ridesharing service. G.M. also pledged to collaborate with Lyft in order to create a readily accessible network of self-driving cars. According to the New York Times, G.M.’s investment represents the “single largest direct investment by an auto manufacturer into a ride-hailing company in the United States . . . .” So why exactly did General Motors, one of the world’s largest automakers, contribute such a significant amount of capital to a business that could eventually cause a decrease in the number of cars on the road?

The short answer is that G.M. views its investment in Lyft as a way to situate itself in a competitive position in the changing transportation industry. As John Zimmer, president of Lyft, said in an interview, the future of cars will not be based on individual ownership: “We strongly believe that autonomous vehicle go-to-market strategy is through a network, not through individual car ownership.” In addition, this partnership will allow G.M. to augment its current profits. The president of G.M., Daniel Ammann, explained that G.M.’s ‘core profit’ predominately comes from cars that are sold outside of the types of urban environments in which Lyft conducts its main operations. Therefore, G.M. can capitalize on its investments by aligning itself at the forefront of this burgeoning automated vehicle industry.

A transition to a network of self-driving cars raises a variety of legal implications, particularly with respect to assigning liability. As Minnesota Journal of Law, Science & Technology Volume 16, Issue 2 author Sarah Aue Palodichuk notes in her article, “Driving into the Digital Age: How SDVs Will Change the Law and its Enforcement,”: “[a]utomated vehicles will eliminate traffic offenses, create traffic offenses, and change the implications of everything from who is driving to how violations are defined.” Underlying all of these changes is the question: who or what is responsible for the operation of self-driving cars? In some states, for example, there must be a human operator who is capable of manual control of the vehicle. As additional states begin to adopt legislation with respect to self-driving cars, it is foreseeable that there will be great debate as to who or what is responsible for purposes of liability. Yet, in the meantime, G.M.’s significant investment in Lyft signals to consumers and state legislators that these issues will need to be resolved quickly, as the automotive industry is moving full-speed ahead.

Marooned on Mars: A Legal Look at Space Piracy

December 16, 2015
International Law, Maritime Law, Space Law

Tim Joyce, MJLST Staffer

Trending on the LawSciBlog’s recent foray into the intersection of law & pop culture, this week our intrepid Staffer corps fact-checks the legal accuracy of certain claims made in Andy Weir’s The Martian. With apologies to the many quality primetime law-connected dramas out there – such as How to Get Away with Murder, Scandal, and The Good Wife (note all the strong female protagonists: go Hollywood!) – this is a science & technology blawg. I will thus attempt to constrain my meanderings to science-related law topics in this book/film.

You may already be familiar with the premise of Hollywood’s most recent riff on the tried and true “We must rescue Matt Damon” formula: an American astronaut with one of the first manned missions to Mars is accidentally left behind during an emergency evacuation. With only his superior botany skills and a can-do attitude, he is forced to “science the s@*t” out of his resources, MacGuyver-style, to avoid starving to death before the rescue mission arrives. Along the way he has all kinds of time alone with his thoughts, and the audience is treated to some hilarious, if occasionally profane, musings.

Author Andy Weir wrote the book as a compilation of various thought experiments he had been entertaining for years. He wanted to know what an actual manned mission to Mars might look like, and what kind of problems might pop up. Although smarter people than I have probed the book’s relative scientific accuracy (hyperlink warning: spoilers inside!), there is one short chapter that explores some legal complications of being the only colonist on an unclaimed planet. Here’s how Matt Damon’s character concludes that he is a “space pirate” (mild spoilers ahead):

  1. An international treaty says: no one can lay claim to anything not on the Earth’s surface.
  2. Another treaty says: if you’re not in any country’s territory then maritime law applies.
  3. The NASA living enclosure and rover are NASA property, and inside American non-military property American law applies.
  4. THEREFORE: Martian land is governed by maritime law; any step outside of his living enclosure or rover vehicle is a journey into “international waters.”
  5. He intends to travel across Martian soil to take control of another NASA vessel.
  6. He has not been able to communicate with NASA to get explicit permission to commandeer this other vessel. (Plot point: communication capability is a major reason he must travel to said ship.)
  7. THEREFORE: By travelling across “international waters” with the intent to commandeer an American non-military vehicle, but without explicit permission, he intends to engage in piracy.

Ergo: space pirate. (If you’re curious, this all happens in the short “Sol 381” chapter.) The character seems to think this is a pretty sweet outcome, but, is he right about the law?

By and large, the answer is yes.

Article II of the Outer Space Treaty guarantees that, “[o]uter space, including the moon and other celestial bodies, is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means.” So, Mars’ surface cannot be claimed by any sovereign party to the treaty. For an exploration of the Treaty’s rationale, see “the common heritage of mankind.”

Further, Article VIII of the Treaty guarantees American jurisdiction over American objects launched into space. So, the living enclosure and rover are definitely under active American jurisdiction on Mars. By extension, anything outside those Earth-originated environments would be “international waters.”

Here’s where it gets tricky.

The other American vessel should still be under American jurisdiction. A trusting reader might assume that NASA would allow its own astronaut to commandeer its other vessel, but we all know what happens when you assume. It is at least plausible that the astronaut had not been given explicit permission to use other NASA spacecraft’s communication devices. Under Article 101 of the United Nations Convention on the Law of the Sea (UNCLOS), which arguably should apply to dispute in outer space, a private person seeking to plunder a ship on the high seas commits an act of piracy. What is unclear is whether an American can be a pirate with regard to NASA property. Weir hurdles this deftly by claiming the astronaut’s botanical cultivation of Martian soil makes him a planetary colonist and the very first human Martian (hence, the book’s title).

That is basically the situation Matt Damon’s character finds himself in, more or less. Certainly, any other astronaut seeking to prevent him from taking control of the other spaceship would view him as a pirate! On the other hand, the assumption that NASA wouldn’t give advance permission for their astronauts to use other Mars-stationed property stretches the limits of believability a bit. And, even if he technically qualifies as a space pirate while travelling to the other vessel, once he gets there and asks NASA politely, he would probably lose technical pirate status.

Is any of this important?

Maybe. Though the current space race isn’t furiously driven like the furious Cold War days, space is becoming ever more crowded as more nations and even private companies enter the game. Even Andy Weir himself admits in a website Q&A that advances in technology since the 60’s make it less justifiable to risk human life to gain scientific data that robots can gather just as easily. It seems like the focus of space law, for the time being, will be a little closer to home. For an in-depth examination of some legal issues surrounding allocation of geostationary orbits, see MJLST Editor Ian Blodger’s article in the upcoming Winter 2016 issue of MJLST.
tl;dr: The legal issue of space piracy may all be just a nerdy thought experiment for the moment. If nothing else, this article should provide you with an interesting conversation starter at the holidays, and a perfect way to change the subject when your non-lawyer relatives start pontificating about the real meaning of the Second Amendment. For now: live long and prosper.

Major Medical Institutions Allegedly Failing to Report Clinical Trials

December 16, 2015
Drug Policy, FDA

Jessica Jayasuriya, MJLST Managing Editor

The Food and Drug Administration Amendments Act of 2007 requires that parties responsible for clinical trials submit clinical trial inform to the Director of NIH no later than one year after either the end date or the estimated end date of the trial.

However, several sources are alleging that Stanford University, Memorial Sloan Kettering Cancer Center, the University of Pennsylvania, the University of Pittsburgh, the University of California San Diego, and other major medical research institutions are failing to submit their clinical trial results within the deadline, and sometimes even at all.

The public database created by the legislation was intended to help the public, particularly medical professionals, scientists, and other researchers, to quickly access the latest findings on human testing of drugs, medical devices, and the like.

Institutions’ failure to turn in their results, however, is directly counteracting this legislative purpose. This is particularly concerning because doctors may not be getting critical information including adverse events in drug trials.

Interviews with the offending institutions indicate that the primary reason for these deadline lapses on the institutions’ end is due to being too busy and a lack of funding. Memorial Sloan Kettering, however, specifically stating it submitted some of its reporting in order to finish medical journal articles related to its trials. On top of institution failures to submit, is clear that the NIH is compounding the issue by failing to follow up on clinical trial deadlines.

Experts interviewed by the sources have further expressed concern that pressure from sponsoring drug companies may also be part of the reason why these clinical trials are not coming to light.

Circumventing EPA Regulations Through Computer Programs

December 16, 2015
Data, Environment, Environmental Law, EPA

Ted Harrington, MJLST Staffer

In September of 2015, it was Volkswagen Group (VW). This December, it was the General Electric Company (GE) finalizing a settlement in the United States District Court in Albany. The use of computer programs or other technology to override, or “cheat,” some type of Environmental Protection Agency (EPA) regulation has become seemingly commonplace.

GE uses silicone as part of its manufacturing process, which results in volatile organic compounds and chlorinated hydrocarbons, both hazardous byproducts. The disposal of hazardous materials is closely regulated by the Resource Conservation and Recovery Act (RCRA). Under this act, the EPA has delegated permitting authority to the New York State Department of Environmental Conservation (DEC). This permitting authority allows the DEC to grant permits for the disposal of hazardous wastes in the form of an NYS Part 373 Permit.

The permit allowed GE to store hazardous waste, operate a landfill, and use two incinerators on-site at its Waterford, NY plant. The permit was originally issued in 1989, and was renewed in 1999. The two incinerators included an “automatic waste feed cutoff system” designed to keep the GE facility in compliance with RCRA and the NYS Part 373 Permit. If the incinerator reached a certain limit, the cutoff system would simply stop feeding more waste.

Between September 2006 and February 2007, the cutoff system was overridden by computer technology, or manually by GE employees, on nearly 2,000 occasions. This resulted in hazardous waste being disposed of in amounts grossly above the limits of the issued permits. In early December, GE quickly settled the claim by paying $2.25 million in civil penalties.

Beyond the extra pollution caused by GE, a broader problem is emerging—in an increasingly technological world, what can be done to prevent companies from skirting regulations using savvy computer programs? With more opportunities than ever to get around regulation using technology, is it even feasible to monitor these companies? It is virtually certain that similar instances will continue to surface, and agencies such as the EPA must be on the forefront of developing preventative technology to slow this trend.

Warrant Now Required for One Type of Federal Surveillance, and May Soon Follow for State Law Enforcement

December 16, 2015
Constitutional Law, Criminal Law, Cyber Security, Data

Steven Graziano, MJLST Staffer

As technology has advanced over the recent decades, law enforcement agencies have expanded their enforcement techniques. One example of these tools is cell-site simulators, otherwise known as sting rays. Put simply, sting rays act as a mock cell tower, detect the use of a specific phone number in a given range, and then uses triangulation to locate the phone. However, the recent, heightened awareness and criticism directed towards government and law enforcement surveillance has affected their potential use. Specifically, many federal law enforcement agencies have been barred from their use without a warrant, and there is current federal legislation pending, which would require state and local law enforcement agents to also gain a warrant before using a sting ray.

Federal law enforcement agencies, specifically Immigration, Secret Service, and Homeland Security agents must obtain search warrants before using sting rays, as announced by the Department of Homeland Security. Homeland Security’s shift in policy comes after the Department of Justice made a similar statement. The DOJ has affirmed that although they had previously used cell-cite simulators without a warrant, going forward they will require law enforcement agencies gain a search warrant supported by probable cause. DOJ agencies directed by this policy include the FBI and the Drug Enforcement Administration. This shift in federal policy was largely in response to pressures put upon Washington by civil liberties groups, as well as the shift in American public’s attitude towards surveillance generally.

Although these policies only affect federal law enforcement agencies, there have also been steps taken to expand the warrant requirement for sting rays to state and local governments. Federal lawmakers have introduced the Cell-Site Simulator Act of 2015, also known as the Stingray Privacy Act, to hold state and local law enforcement to the same Fourth Amendment standards as the federal government. The law has been proposed in the House of Representatives by Rep. Jason Chaffetz (R-Utah) and was designated to a congressional committee on November 2, 2015, which will consider it before sending it to the entire House or Senate. In addition to requiring a warrant, the act also requires prosecutors and investigators to disclose to judges that the technology they intend to use in execution of the warrant is specifically a sting ray. The proposed law was partially a response to a critique of the federal warrant requirement, name that it did not compel state or local law enforcement to also obtain a search warrant.

The use of advanced surveillance programs by federal, state, and local law enforcement, has been a controversial subject recently. Although law enforcement has a duty to fully enforce that law, and this includes using the entirety of its resources to detect possible crimes, it must still adhere to the constitutional protections laid out in the Fourth Amendment when doing so. Technology chances and advances rapidly, and sometimes it takes the law some time to adapt. However, the shift in policy at all levels of government, shows that the law may be beginning to catch up to law enforcement’s use of technology.

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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