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3D Printing: New Life Sciences Technology and Old Product Liability Claims

August 1, 2016

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

—By Angela Vicari

Angela Vicari on 3D Printing: New Technology, Old Product Liability Issues

The potential of 3D printing 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, the relative accessibility of 3D printing 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. The ability of 3D printing 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 manufacturers 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.

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