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James Beck is the senior life sciences policy analyst at Reed Smith. James is specialized in product liability, personal injury, especially in very large and very complex cases. Active in law for over thirty years he has been involved in cases U.S. District Court for the Eastern District of Pennsylvania, the U.S. Court of Appeals, Third Circuit and the Supreme Court. He is involved in mass torts, many amicus curiae briefs he is an award-winning expert in his chosen fields who writes often about the law. Over the past few years, James has taken an active interest in 3D Printing, especially with regards to product liability. He is part of Reed Smith’s 3D Printing team who take an active interest in all things printed. Reed Smith itself is a 1500 lawyer law firm with 28 offices around the world and over a billion dollars in revenue. It is both nice and significant when people like that take an active interest in our industry and technology. We interviewed James to find out more about 3D printing and the law, specifically product liability.

If I design a file and someone prints it out at home will there be product liability?

As a theoretical matter, there could be “product liability” of a sort. It may not be strict liability as is common in the USA, because it is questionable whether the CAD files are “products.” Under USA law “products” must be tangible things. There could still be negligence or warranty liability. As a practical matter, the plaintiff would have to be able to identify the file designer and be able to obtain jurisdiction over that person. If the file is open source, and the designer is located in another country, that could present significant problems.

What do I have to be mindful of when sharing 3D printable files online?

Are the files capable of being corrupted in the upload/download process? Are you in the business of sharing such files as part of your business, or are you doing this as a hobby? If the latter, then that is another defense to product liability. If the files have been pirated, and the original owner’s trademarks are still on it, any problem could result in a lawsuit against the original owner. It would probably be dismissed, unless some duty to prevent counterfeiting is created, but the litigation fees and time would still be an unwanted headache.

What if someone else designs it and I print out and sell the product?

If this is done as a business, both sides to this transactions should have a contract governing who is liable for what, and who (if anyone) is responsible for insurance. Anybody who prints out a product is likely strictly liable as a manufacturer, or at least an intermediate seller (in the USA the liability is mostly the same).

What should companies selling 3D printed goods to do legally protect themselves?

Insurance is a good idea, as are contracts and, as a last resort, disclaimers on websites that any purchaser must click on and acknowledge before continuing. As a practical matter, staying off-shore and selling through platforms like Amazon should make such sellers very difficult to sue successfully. The 3D printed output should be tested to make sure that it performs as expected before it is sold. Restrictions on the substrate used to create the products should be so prominent they are impossible to miss. Use of available cooperative facilities with 3D printer manufacturers (some of whom offer certification and other services) or public 3D printing facilities is also a good idea where possible.

Are there any special considerations if I want to patent or otherwise protect 3D printed designs?

I’m not a patent lawyer, so I can’t opine on intellectual property issues. 3D printing makes counterfeiting very easy. From a product liability standpoint, a patent makes you more identifiable as a party that could be sued in event of an injury. Most US jurisdictions refuse to hold patent holders, who are not also manufacturers, liable, but there are a few exceptions, and the law could move in that direction. An end user with a household 3D printer will have a hard time suing over defects in products that s/he printed out, but one possible target would be the designer/patent holder. A lot will depend on who has deep pockets to pay a judgment.

How do we share 3D printed designs and change them while ensuring attribution?

First, make sure this is what you want to do from a product liability standpoint. In an open source situation, the designer may well not be an identifiable person, which would make bringing a suit against the product designer impossible.

Otherwise, ensuring attribution in a file sharing environment would involve both contracts between the sharers (assuming they are trusted), and technological changes to the CAD software to limit how it can be used by a third party. There may also be a role for Blockchain in this, but I don’t understand Blockchain well enough to opine on it.

What 3D printing legislation do you anticipate?

For the moment, not much. Action by national and international standards organizations is currently underway. There is also an ALI “Principles of Software Contracts” that would apply to some of the business issues. If voluntary standards do not work, then eventually US states or the federal government could impose minimum standards, and could do things like impose strict liability regardless of CAD files being “products” under the common law.

Ultimately, I would not be surprised to see some sort of “no fault” system of recovery, funded from taxes on 3D printing equipment and raw materials, under which injuries caused by 3D printed products are compensated.

Do you think it’s a good idea that lawmakers are making new legislation just for 3D printing?

Generally not, because the need for legislation is indicative of serious problems that the marketplace has been unable to solve on its own, but that is just my personal philosophical outlook.

What kind of litigation do you anticipate?

What I worry about most is the targeting of 3D printer manufacturers. Finding defendants that can practically be sued will be a major problem with litigation over products printed with CAD files downloaded from the Internet. Often the injured person will have operated the printer and “made” the product. Trying to trace who did what in the cloud, and to sue people overseas will be difficult and expensive. The 3D printer manufacturer will be identifiable, and probably a large company that can easily be identified and sued. However, such suits will disrupt the entire industry because a 3D printer manufacturer cannot reasonably be expected to know, investigate, and be responsible for the safety of every CAD file that runs on one of its printers. If an injured person cannot sue him/herself (that is to say, recover from his/her insurance company), and can’t sue the printer manufacturer, then those are situations where I expect to see litigation against designers of CAD files, to the extent they are identifiable, and have deep enough pockets.

When is a 3D printed product defective?

I doubt the usual definition of “defect” will change simply due to the provenance of a product. Products are typically considered “defective” in the US if they pose “unreasonable danger” to intended or foreseeable users. That can be determined either by consumer expectations (is the danger “unknowable and unacceptable to an ordinary consumer”) or by “risk/utility,” which is based on a balancing of a wide variety of factors, including alternative designs, obviousness of the danger, and warnings. A defect can also arise in the manufacturing of a product if it fails to meet the specifications that the manufacturer intended it to have. If a CAD file is somehow corrupted, 3D printing could easily produce products with manufacturing defects. In this respect, 3D printing is just another method of manufacture.

How can I share design files for an open source 3D Printer safely online?

Open source designers are probably safe from product liability litigation due to their anonymity. Platforms providing opportunities for open source collaboration are probably safe from product liability litigation as a result of the Communications Decency Act, which preempts lawsuits over website content. I am not capable of answering questions about protecting intellectual property in an open source environment.

If a company has a spare part can I just copy that part and print it? What could happen if I do?

Usually the company has as patent, copyright, or at least a trademark on its design. I expect large companies with many parts designs on many products (such as car makers) to move to 3D printing as an alternative to having to maintain massive inventory of parts for older models. If a third party using a scanner, or hacked files, starts 3D printing a company’s parts, there will likely be intellectual property litigation. From a product liability perspective, anyone who 3D prints a part is a seller liable for a defect in the part as a manufacturer.

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