United States: 3D Printing: New Life Sciences Technology And Old Product Liability Claims (Video Content)

3D printing's potential to revolutionize the medical device and drug industries also brings product liability risks. Just as 3D printing technology upends how devices and drugs can be manufactured and delivered, future cases alleging injuries caused by 3D-printed products will present fact patterns and legal issues that challenge traditional notions of product liability.

3D printing and healthcare today

3D printing technology, aka additive manufacturing, begins with a digital design for an object, generally in the form of a computer-aided design (CAD) file that is transmitted to a 3D printer. The printer creates a final, three-dimensional product by consecutively applying thin layers of material, such as plastic or metal, one on top of the other, until the object is formed.

These techniques have been applied in the life sciences industry. The first 3D-printed drug approved by the FDA, in 2015, assembled the drug by thinly applying multiple layers of powdered medication without using compression forces or traditional molding techniques.

Although there is only one FDA-approved 3D-printed drug on the market, 3D printing has already been used to create medical devices such as prosthetics, dental implants, hearing aids, and bone grafts. An estimated 85 or more 3D-printed medical devices have already received FDA approval.

In addition, "bioprinting" is a particular type of 3D printing that uses cells or tissue as material in the printing process, instead of plastic or metal. This technology is already being used to generate liver tissue for use in drug testing.

3D printing potentially disrupts "product" definition and distribution

More than a mere manufacturing process, 3D printing's relative accessibility has the potential to turn the traditional chain of distribution for medical devices and drugs—from manufacturer to dispensing point (e.g., a hospital, pharmacy, etc.) to patient—on its head. 3D printing's ability to create and deliver highly customized medical products and services further adds to its potential to serve patients outside of the traditional chain of distribution.

As non-traditional distribution chains emerge to deliver devices and drugs created using 3D printing, the courts will be challenged with novel questions in what would otherwise be traditional product liability cases. For example, what will happen when device and drug companies sell a CAD file instead of a finished product to hospitals and doctors, which then use it to print a personalized medical device or drug? Is the CAD file itself a "product?" What theories of liability can be applied to the seller of the digital file? Can the hospital or doctor now be liable in strict liability?

While the language of product liability law reflects a focus on tangible items, courts typically examine whether they are tangible vs. intangible, as well as the context of its distribution when considering whether something is a "product." Given the complicated examination, the line between what constitutes a "product" and what does not can be blurry. Plainly, the medical device or drug that is actually created by a 3D printer is a "tangible" product, but what about the digital file that serves as the blueprint for making the final product? Is that a "product," for purposes of product liability law?

What is a "product" anyway?

In addressing the question of whether CAD files are "products," it helps to examine where courts have historically drawn the line on what constitutes a product for purposes of strict liability. The patchwork of case law discussed below does not answer the question of whether or when a CAD file is a product, but it does provide both plaintiffs and defendants with an arsenal of arguments as lawsuits involving 3D-printed objects become more common.

  • Computer source code and software

Outside of the federal criminal statutes content—see U.S. v. Aleynikov, in which the Second Circuit reversed a criminal defendant's conviction of trade secret theft from Goldman Sachs' high-frequency trading platform under the National Stolen Property Act and espionage under the Economic Espionage Act, on the grounds that Goldman's system "was neither 'produced for' nor 'placed in' interstate or foreign commerce"—there are several cases that may bear on the issue of whether digital blueprints for 3D-printed products are themselves products.

At least two courts have suggested that computer software might be considered a product for purposes of strict products liability in tort (Winter v. G.P. Putnam's Sons (9th Cir. 1991); Schafer v. State Farm Fire & Cas. Co. (E.D. La. 2007)). There is also a nuanced line of case law under the Uniform Commercial Code: Software that is mass-marketed is considered goods (Systems Design v. Kansas City Post Office, (Kan. Ct. App. 1990); Advent Sys. Ltd. v. Unisys Corp. (3d Cir. 1991); RRX Indus., Inc. v. Lab- Con, Inc. (9th Cir. 1985)), while software that is developed specifically for a customer is a service (Data Processing Servs., Inc. v. L.H. Smith Oil Corp. (Ind. Ct. App.1986); Micro-Managers, Inc. v. Gregory (Wis. Ct. App. 1988)). If these computer source code and software cases become the foundation for handling product liability cases involving 3D-printed medical devices and drugs, whether the creator of a digital blueprint can be held liable in strict liability may depend on how the file is marketed.

  • Information in navigational charts and maps

Inaccurate data in a navigational chart that is linked to an accident has been considered a product (Fluor Corp. v. Jeppesen & Co. (Cal. Ct. App. 1985); Brocklesby v. United States, (9th Cir. 1985). The import of Fluor and cases like it for injuries caused by 3D-printed products is obvious. Fluor stands for the proposition that an injury does not have to be caused by impact from the physical properties of an item. Under this rationale, if a person is injured by a product created by a CAD file, the file could be considered a product.

  • Content of video games and books

Courts have consistently held that the intangible thoughts, ideas, and expressive content in video games do not constitute products for purposes of strict liability (Sanders v. Acclaim Entertainment, Inc. (D. Colo. 2002); Wilson v. Midway Games, Inc. (D. Conn. 2002); James v. Meow Media, Inc. (W.D. Ky. 2000), aff'd 300 F.3D 683 (6th Cir. 2002); Gorran v. Atkins Nutritionals, Inc.). Like the video games and books in these cases, the CAD file used to create a 3D-printed medical device or drug will not itself physically injure a patient. However, unlike the video games and books, the CAD file is not an intangible thought or idea. Subjecting its creators to strict liability may not raise the type of free speech issues that are seen in the video game and books cases. Instead, the CAD file serves as a digital blueprint for a product that itself causes an injury. Although it may be tempting to apply the video game and book cases to the 3D printing paradigm, fundamental differences in their fact patterns may render them of limited import.

  • Architectural drawings

Designs, technical drawings, and professional advice are considered "services" and not "products" for purposes of strict liability law (Snyder v. ISC Alloys, Ltd. (W.D. Pa. 1991); City of Mounds View v. Walijarvi (Minn. 1978)). Just as architectural drawings are literally the blueprints for a finished tangible product, a CAD file to create a 3D-printed medical device or drug serves the same purpose. However, the relationship between an architect and her client is markedly different than the relationship that will likely be formed between a device or drug manufacturer and the purchaser of a CAD file. For that reason, although both are blueprints, courts may be more likely to impose strict liability on a drug and device CAD file "manufacturer" than an architect.

Are human tissue and organs "products?"

Although human blood and tissue fit the technical definition of tangible property, they are specifically excluded from the coverage of the Restatement (Third) of Torts: Prod. Liab. § 19(c). If technology continues to advance at its current pace, it will not be long until courts start to see cases in which a plaintiff alleges injury as a result of defectively bio-printed tissues. Farther into the future, courts will have to address product liability cases involving 3D-printed organs. Whether courts will follow the Restatement approach of exempting such cases from strict liability or consider tissue and organs to be subject to the same rules as other tangible items remains to be seen.

Who are potential defendants?

In a future product liability case in which a patient alleges injury from a 3D-printed medical device, organ or drug, there are several potential defendants, including the 3D printer manufacturer, the device or pharmaceutical company, and the hospitals and doctors who treat patients.

  • Imposing liability on the 3D printer manufacturer is unlikely, unless the alleged injury is caused by a defect in the 3D printer itself.
  • If medical device and drug manufacturers no longer "manufacture" anything tangible at all, and become designers and sellers of digital files that contain the blueprint for others to print medical devices and drugs using their own 3D printers, would they be immune from liability under a strict liability theory? The answer could depend on how courts answer the question of whether a digital file is a "product." If a digital file is not a product, then companies that design and sell digital blueprints are not "engaged in the business of selling or otherwise distributing products." But does it make sense to exempt such companies from strict liability? The same rationale that imposes strict liability on today's drug and device manufactures will be used by plaintiffs' attorneys in the future to hold commercial sellers of digital blueprints strictly liable for injuries allegedly caused by the 3D-printed products created from those blueprints.
  • An overwhelming majority of jurisdictions refuse to apply strict liability principles to claims against hospitals and physicians involving the distribution of allegedly dangerous medical devices or drugs, reasoning that hospitals and physicians provide services rather than products. While these holdings may make sense when products are sold using a traditional distribution system, what if hospitals start to incorporate a 3D-printing center onsite? Is the hospital "engaged in the business of selling" the 3D- printed product? Is it more likely that a hospital is engaged in the business of selling the 3D-printed product if patients choose that hospital because they know that they can purchase custom-3D-printed devices there? How many devices would a hospital or doctor have to print to be considered more than a "casual" or "occasional" seller? In considering these questions, courts may part ways with the traditional rule that exempts hospitals and doctors from strict liability.

Regulatory Considerations

A product's regulatory history and classification plays a major role in drug and device product liability litigation. How the FDA regulates 3D-printed drugs and medical devices now and in the future will impact the merits and strengths of both claims and defenses. On May 10, 2016, FDA issued a draft guidance entitled "Technical Considerations for Additive Manufactured Devices." This "leap-frog" guidance represents the Agency's "initial thinking" on design, manufacturing, and testing considerations for 3D-printed medical devices. Most of the guidance will not change the product liability calculus at this time because the FDA's overall criteria for evaluating, testing and approving 3D-printed devices remains the same as traditionally manufactured devices. The sole exception to this is with respect to labeling for customized "patient-matched" devices. For these types of devices, the FDA recommends that a precaution be included in the labeling, stating that the patient should be checked for potential anatomical changes that may have occurred between the time that a patient's initial scans were taken and when the customized 3D-printed product based on those scans is to be implanted.

For purposes of future product liability litigation, there are two important areas that are not addressed in the guidance, namely issues presented by point-of-care manufacturing and bioprinting. With the respect to these two topics, the FDA acknowledges that they may raise additional technical considerations and necessitate additional regulatory and manufacturing process considerations and/or different regulatory pathways. Like the rest of us, the FDA is paying careful attention to the evolution of 3D printing.

Conclusion

Because law often lags behind technology and science, the presence and impending proliferation of 3D-printed medical devices and drugs raise more tort-related questions than it answers. Although the questions addressed above are theoretical now, they will soon become reality; it's unclear how the courts will respond. One thing, however, is certain: Our legal system does not allow perceived "wrongs" to be left without remedy for long. As attorneys who defend medical device and drug manufacturers, we must prepare as diligently as we can to develop our best defenses and be prepared when the first product liability cases involving 3D-printed products are filed.

» Read the full article on Medical Design & Outsourcing.

Originally appeared in Medical Design & Outsourcing on August 1, 2016.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
In association with
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.