Ideas and suggestions are always welcome. Please let us know how we can improve your newsletter! We welcome your feedback.
LexisNexis® for Corporate Counsel
LexisNexis® Webinar Center
LexisNexis® Legal Newsroom
Live CLE Webinars | OnDemand Webinars
Edited by: Colleen Davies, Partner, Reed Smith LLPMatthew Jacobson, Associate, Reed Smith LLP Lisa Baird, Counsel, Reed Smith LLP Farah Tabibkhoei, Associate, Reed Smith LLP
Attention cyberphobics, robophobics and technophobics: You now have a new monster under your bed!
One day 3D printers will be able to make just about anything. They already can machine parts, medical devices and firearms. One thing they also will create will be challenges to existing laws and regulations in a number of areas of law.
A multidisciplinary team at the international law firm of Reed Smith recently published a 57-page white paper that detailed what they see as the coming legal complications and risks associated with the increased use of 3D printers. CLICK HERE to download the white paper.
The Reed Smith team focused on seven areas. Here, with their permission, we are offering some highlights. The paper goes into much more detail—complete with citations—than we have room for here. One acronym you will want to learn is CAD, which stands for computer-assisted or computer-aided design. It’s the CAD programs that contain the data that directs 3D printers. Here is some of what is contained in the Reed Smith white paper.
One million guns are sold each month in the U.S., the white paper reads, and with the advent of 3D printing you can now make an untraceable gun at home. Since the printed firearm will be made of plastic, it will get through metal detectors. Untraceable, undetectable guns is a concept being addressed with legislation in Philadelphia, which requires you to have a license to print guns. In California, starting in July 2018, anyone wishing to print a gun will be required to do things like imprint them with government-issued serial numbers and include enough metal in the firearms to be detected by metal detectors, the Reed Smith team writes.
The Reed Smith attorneys say a case to watch is now in the Fifth Circuit, Defense Distributed v. U.S. Department of State, which challenges the State Department’s Directorate of Defense Trade Controls designation of CAD files as “defense articles” and therefore subject to regulation. A company called Defense Distributed sued when the Directorate of Defense Trade Controls (DDTC) ordered it to remove digital gun designs from its website because of the danger the weapons would cause to security internationally, including by terrorist groups. Defense Distributed cited the First and Second Amendment. A federal court in Texas ruled for the government, saying it had substantial interest in regulating this information abroad and there was no bar to domestic communication. The Fifth Circuit affirmed the District Court given the government’s “exceptionally strong interest” in national defense and security. The court also noted that the files released by Defense Distributed continue to be hosted by foreign web pages. The court did not address the Second Amendment. Defense Distributed has requested an en banc review.
The Reed Smith team outlines these areas of concern:
“As 3D printing becomes more commonplace, it is only a matter of time before courts are faced with the quandary of whether traditional tort liability principles will apply to 3D printed products and manufacturing techniques, or whether new laws will need to be created,” the Reed Smith team writes.
Although 3D products are made differently than traditional products, the Reed Smith attorneys say the products will not be considered any different in the courts.
“To the extent, however, that 3D printers are operated by other entities—specialty 3D printing stores, professionals using products in the performance of their services, parts suppliers, hobbyists and most disruptively, end-use consumers—strict liability is unlikely to provide remedies to persons injured by 3D printed products,” the attorneys write. “Moreover, if the sale is of a CAD file that can be printed anywhere, the product may not be the end result, but the computer file itself. This causes numerous legal issues, as well as the practical problem of the CAD file creator not being amenable to jurisdiction, not having assets available to satisfy judgments or in some cases being unidentifiable. The advent of 3D printing has multiplied the number of possible 'products' and 'manufacturers,' and thereby is poised to scramble the traditional 'manufacturer'-based chain-of-sale concept on which strict liability has been based. Issues that arise with the intersection of 3D printing and tort liability include (1) what is the 'product'; (2) what is a 'sale'; (3) who is a 'manufacturer'; (4) product identification; and (5) redefining manufacturing, design and warnings defects.”
With those challenges, personal injury plaintiffs may need to look to negligence claims, the attorneys write. But then, they say, a plaintiff must prove the existence of a duty of care, breach of that duty, proximate causation, and resulting damages. “But,” they ask, “who owes a duty of care to the plaintiff?”
“The seller of a 3D printed product likely owes a duty of care. The individual or entity who printed the product likely does as well,” the white paper reads. “The designer of the CAD file may have a duty to even an unknown third party, depending on whether the plaintiff suffered personal or economic injuries. Courts applying the economic loss rule have held that software developers do not have a duty of care to avoid intangible economic loss or emotional distress, and thus cannot be liable for negligence unless their software caused physical damages. Other designers, such as architects and engineers, who provide design input but are not involved in manufacturing, may be liable in tort for their negligence. Thus, a designer of a CAD file that creates a defective product may be liable in negligence, even if he did not ultimately manufacture the final product."
But if the manufacturer or seller of the 3D printed product has such a duty of care, what does that duty entail?
“Generally, a manufacturer or seller has a legal duty to use reasonable care in response to a foreseeable risk of injury to others. When a manufacturer or seller knows or should know of unreasonable dangers associated with the use of the product and such dangers are not obvious to the user, there is a duty to warn of the dangers. Under these principles, CAD files, by themselves, may not present unreasonable and unknown dangers triggering a duty to warn, since computer code is not inherently dangerous. On the other hand, if a designer or seller distributes CAD files on how to 3D print a firearm, presumably a duty to warn of the dangers of the gun arises.”
Regarding potential liability of the manufacturer of the printer itself, the attorneys say that unless the printer itself causes harm, pursuing the manufacturer would be like going after a toolmaker for items made by the tool.
Environmental harm, safety risks and liability concerns are risks manufacturers and suppliers should watch, the attorneys write, if, for example, 3D printed products include defects that injure end users.
“Consumer products, including medical devices, frequently comprise component parts and raw materials manufactured or supplied by unrelated entities, are assembled, and then sold as a finished product. If this product happens to be defective and injures its end user, a question arises regarding the apportionment of responsibility for the injury. The manufacturer of the final product could be liable, or, depending on the jurisdiction, the law may also apportion responsibility to the manufacturer of the defective component part or raw material that was incorporated into the final product and caused the injury,” the paper reads.
As with any disruption in business and law, its impact makes its way to an industry whose very business model depends on some things staying the same: the insurance industry. Are existing policies adequate? Will additional insurance be needed?
“Because 3D printing will blur the line between manufacturers and end users, it will create challenges in apportioning liabilities and pose accountability and traceability issues,” the Reed Smith team says. “As this type of 3D printing activity takes place, it will become increasingly difficult for insurers to identify the liable party.”
The attorneys offer a situation in which a hobbyist sells something he printed in his garage, then that something injures the buyer. Will they hobbyist’s homeowner’s policy provide coverage or will it be barred by a business exclusion? “Not only does the finished 3D printed object present risks requiring insurance, but the 3D printing process itself also calls for environmental liability insurance because of the potential for raw materials being used to print 3D objects to release fine toxic particles into the atmosphere.”
While the proliferation of 3D printing may pose new challenges to traditional IP enforcement, there will be “affirmative measures” IP holders can take to adapt to its larger role in manufacturing, the Reed Smith attorneys write.
For example, they say, an anti-counterfeiting protocol would include using proprietary and confidential product markings to tag genuine products and parts. They say actions before the U.S. International Trade Commission (ITC) to enjoin importation of counterfeit goods may help keep infringing goods off the market "even when enforcement against individual users, printers and/or distributors of 3D-printed goods might be difficult.”
They suggest a protocol for policing websites that allow CAD file sharing and making sites remove unauthorized design copies—doing so under the Digital Millennium Copyright Act (DMCA).
“A preemptive IP protection strategy, which evaluates whether to seek patent protection not just for covered products as a whole, but also for their component parts and methods of use—as well as possible opportunities for trademark and/or trade dress protection—may help manufacturers develop a portfolio of IP rights more specifically suited to protecting against encroachment from 3D printing,” the Reed Smith paper says. “Additionally, careful claim drafting may help patent owners enforce their rights against the importation and/or distribution of 3D files under certain circumstances. 35 U.S.C. § 271(g) prohibits the importation of goods manufactured abroad using a process patented in the United States.”
3D printers store confidential information, such as schematics, customer configurations and system logs. The loss of that data can compromise trade secrets and intellectual property protection. When 3D printers are used to make medical devices, exfiltration of a patient’s personally identifiable information, or PII, could trigger security and privacy laws, the attorneys write.
In addition to medical devices, the Reed Smith attorneys explain, 3D printers can also make parts for autonomous or manned aircraft, heavy machinery and weaponry. “It is therefore critical that 3D printers and associated computing devices are equipped with safeguards that protect the integrity of the design schematics and manufacturing process.” They also call out the potential strict product liability risks a manufacturer may face if they produce defective items.
Design tampering also is a risk. They say that “a bad actor who gains access to a 3D printer or a schematics repository could make modifications or introduce manufacturing flaws in the printing process that will result in products with potentially undetectable defects that may cause critical failures during use.”
“… 3D printers and the broader 3D printing ecosystem face cybersecurity and privacy challenges with significant legal and business risks that need to be addressed by responsible organizations. Although some of the underlying challenges are similar to the threats facing other types of connected devices, the nature of 3D printers and increasing reliance on 3D printed objects with a wide array of use cases present unique issues that need careful attention. High-profile failures of 3D printed objects as a result of maliciously introduced defects could result in a loss of public faith in the technology, and significant impact on the industry at large.”
3D printing, given the print cartridges contain substances needed to mold objects, is also called “additive manufacturing.”
On the positive side, the Reed Smith paper says, this process has potential to provide “significant environmental benefits over traditional manufacturing techniques.” They say 3D printers reduce waste (they use only what they need), eliminate the need for transportation (and resulting vehicle emissions) and reduce operating costs.
However, the team at Reed Smith says “the potential environmental hazards must be closely monitored as 3D printing technology evolves.” They point to a variety of materials and chemicals involved, the potential for occupational and environmental exposures. “If the printing operation is occurring at a consumer level,” they warn, “workplace safety precautions and infrastructure will not be present, so additional safeguards need to be identified and communicated to the consumer. Printer parts (e.g., printer cartridges) may offer the benefits of re-use and recycling, but precautions will be necessary if the chemical constituents used in the cartridges are themselves hazardous.”
CLICK HERE to download the complete 57-page white paper.
This article was edited for LexisNexis by Tom Hagy, managing director of HB Litigation Conferences and former publisher of Mealey’s® Litigation Reports.