In the last few years the range of printing materials has dramatically increased to include steel, gold, titanium, ceramics, gypsum and biological materials, to name only a few. The almost unlimited range of printing materials has quickly moved 3D printing from making models and prototypes to the manufacture of finished products. These products fall into a wide variety of classes:

• Medical devices: hearing aids, dental crowns, surgical instruments, implants, etc.

• Automobile and aircraft parts

• Construction materials (some printed on site) or bespoke casts for unique parts

• Drugs (dosages created for specific patients and conditions)

• Food

• Consumer goods: clothing, toys, wearable monitors, replacement parts for older products

In August 2017, cosmonauts launched 3D printed satellites from the International Space Station. Most of the parts for the satellites were created in outer space, thus greatly reducing the cost of launching a satellite.

Until recently, it was assumed that 3D printing would be limited to unique or small batch production because 3D-printed products take more time to finish due to the printing technique. This limiting factor is changing as printing methodology is improved. For example, Adidas recently announced that it was planning two factories that can create up to 500,000 pairs of shoes each year.

Products created by 3D printers can be made as needed in almost any setting. (Photo: Shutterstock)

The benefits of 3D-printed products

Just like computers and the internet, which originally had specific and limited uses, 3D printing is rapidly expanding its scope of utility. Here are several new uses:

• New designs can be created and printed rapidly for lab or field testing.

• One-off and complex designs are made without the need for re-tooling molds.

• A variety of materials can be experimented with in a short period of time.

• Reduction of inventories and “just-in-time” creation of parts or products.

• Products can be made on-site in remote locations or outer space.

• 3D printing by its nature is less wasteful than traditional methods.

• 3D printers can make products that are otherwise impossible or impractical to make.

Claims issues arising from 3D-printed products

The fact that a product is designed and manufactured using 3D printing, as opposed to traditional subtractive methods, does not affect the tort liability of the manufacturer, distributor or seller of the product. The same laws of product liability apply as found in the Restatement of Torts and interpreted by individual states.

Generally, the seller of a defective product is liable for the harm caused by the product to a user or to property. The same defenses to claims of defect in design or manufacture can also be raised by defendants in chain of commerce.

3D printing adds some new twists to products liability that need careful analysis by claims representatives and defense lawyers. In addition to determining if the product was defective and caused harm arising from the defect, several questions should be asked:

• Is the printer manufacturer partly or wholly liable for the defect?

• Was the design software used to print the product defective?

• Was the digital file corrupted between its creation and its use?

• Were the materials supplied to the manufacturer the cause of the defect?

• Was the design altered by anyone including the 3D file sharer?

• Did human error affect any stage of the 3D printing process?

For American product liability laws to apply to a product, it must be “sold.” In the context of uniquely designed 3D printed products, one must determine if a sale took place. If plaintiffs seek to recover under strict liability, they must prove several things:

• The defendant regularly makes, markets, distributes or sells products as part of its business. If the vendor only made a unique product for a specific purpose or customer, they may not be considered to be regularly engaging in commercial activity that subjects them to strict liability.

• Individuals or hobbyists who make products in their spare time would have to be shown to be in the business of making such products.

• The plaintiff must prove that the product was made by a commercial manufacturer or seller. Thus, an occasional product printer who makes a 3D printed product for a commercial retailer may not be strictly liable, although the retailer may have such liability.

Related: Liability claims: Emerging technological influences to watch

Flaws in the designs may be undetectable until a product is manufactured and used by the person who downloaded the design. (Photo: Shutterstock)

Other challenges

3D printing will create new challenges for determining liability issues. These include:

• Accountability

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  • Who was the original designer and at what stage and by whom were changes to the design made?

• Traceability

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  • Was the design stored in and retrieved from a file server? If the design was emailed, can it be determined if the design was substituted or altered?

• Apportionment of liability

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  • In states without joint and several liability, how much fault might be attributed to any of the parties involved in the design?

• Jurisdiction issues

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  • 3D software designers may be remote from manufacturers and end-users.

End-users as manufacturers

The typical product liability analysis revolves around finding the manufacturer, distributor and seller of a product. 3D printing is changing this as more products are made by the end-user. This is especially true in the medical field.

Physicians and dentists find that printing custom-designed products for specific patients improves performance, reduces operating times and lowers risk. 3D printers can produce preoperative planning models of tumors, organs and bones. Increasingly, 3D printers are making implants, casts and orthodontia devices in doctors' offices and hospitals.

Doctors and hospitals that design or print their own medical devices bring the risks associated with product manufacturing upon themselves. Whether they are “engaged in the business of selling” the product or placing it into the stream of commerce in a way to invoke strict liability remains to be seen. Traditional negligence theories and warranty claims will be available to plaintiffs who believe their products were defective or failed.

Open source 3D print designs

Thousands of 3D-printed product designs exist on privatefile servers and open sources in the cloud. Flaws in the designs may be undetectable until the product is manufactured and put to use by the person who downloaded the design.

When the product fails causing harm to a person or property, tracing the design flaw back to the designer may be impossible. A secondary consideration is whether the printer used the precise materials specified for the design and if they were printed under conditions that would be required to make the product work as intended.

The dynamic nature of 3D printing has vaulted products made using this technology ahead of the law in many cases. It may be years before we have a definitive answer. In the meantime, claims representatives and defense lawyers need to be familiar with the design and manufacturing processes of 3D printing in order to allocate fault appropriately and defend insureds from claims arising from products made on 3D printers.

Christopher C. Iliff, JD, ([email protected]) is a senior vice president with Swiss Re.