1509-Technology-and-electronic-productsWhen we wrote back in November 2013 about 3D Printing and Product Liability Law, we predicted that the 3D printing revolution “will challenge our long-held notions of product liability law and the common assumptions made regarding the liability of various entities in the chain of distribution.” Our blog challenged the reader to think about who the manufacturer would be under the make-believe fact scenario we posed for an injury allegedly caused by a 3D-printed product.

Our prediction about the challenge to our long-held notions of product liability law posed by 3D printing (a/k/a stereotactic lithography) appears to be coming true. Many are of the opinion that the occasional use of a 3D printer – even one that produces a defective product – would not give rise to strict product liability. Typically, the commercial sellers of products, and not the hobbyist, are at risk. Others have questioned the potential liability of one whose design is used by the 3D printer inasmuch as her intellectual property is generally not considered a tangible “product” that could give rise to strict liability. So, who is left – the manufacturer of the 3D printer hardware? Perhaps, but how is its liability any different than the manufacturer of a press brake that was used to create an allegedly defective widget? How is the standing of the 3D printer manufacturer any different than the manufacturer of an oven that allegedly baked “defective” food products?

What if I used a 3D printer to make an exact replica of Michelangelo’s Pieta to display in my museum in the States  and thereby make travel to Rome unnecessary to “experience” the Renaissance masterpiece? Have I broken some kind of law? What if I use my left running shoe to replicate and replace my lost right running shoe? Have I violated the manufacturer’s patent?  As 3D printing becomes more accessible to the consumer given technological advances and decreased costs, product manufacturers and their insurers and lawyers – as well as those dealing with intellectual property and constitutional law – will need to deal with these interesting questions.

Growth in the Industry
Meanwhile, the 3D printing industry continues to take off. Although some individual “3D” stocks have taken a hit during the past year, by one estimate the industry overall grew at a compound annual rate of over 30 percent from 2012 to 2014 and is now a $4 billion segment of the economy. It is expected to surpass $20 billion in sales by 2020.

Much of this projected growth will undoubtedly take place in the medical devices field, which has already seen the development of a number of 3D-printed medical products, particularly in the orthopedic and dental fields. 3D-printed medical products have even extended into implantable devices such as spinal columns or segments. The drive to create these devices extends well beyond the traditional medical manufacturing sphere, as evidenced by the story of 17-year-old Frank Nguyen, a student from Toronto’s Ryerson University. As part of a summer school project, Nguyen used 3D printing to design and manufacture a heart monitor for his ailing mother to wear on her wrist. The monitor, which he named the “HelpWear HeartWatch,” tracks his mother’s heart rate and is capable of sending a text message to alert a caregiver in the event she experiences an abnormal heart rate that continues through a series of re-checks conducted by the watch.

3D-printed drugs are also making their way to the marketplace. An Ohio-based pharmaceutical manufacturer recently announced that the FDA had approved 3D printing of its anti-epilepsy drug. The use of 3D printing has allowed this manufacturer to increase the content of the active ingredient in each tablet, while decreasing tablet size and making the tablet easier for patients to swallow. Given this recent development, we expect other manufacturers to follow suit and secure the FDA’s approval for their own 3D-printed drugs in the near future.

3D Printing and the Law
These impressive strides forward in 3D printing technology are certain to have ramifications in the legal field. The coming years will determine how manufacturers, lawyers and regulators sort out the interesting legal problems presented by this emerging technology. Hopefully, the legal industry can do so in a way that does not hinder continued innovation.

As always, we invite our readers to submit their thoughts on the topic.

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Photo of Rosario M. Vignali Rosario M. Vignali

Russ Vignali is a tenacious advocate who focuses his litigation practice on the defense of products liability matters and related commercial disputes in New York state and federal courts. He also handles a variety of claims in the general liability area and has experience with related insurance coverage matters. Russ joined Wilson Elser in 1982 out of law school and developed his service approach within a firm culture that values a high level of responsiveness and open communication with clients.

Photo of Genese K. Dopson Genese K. Dopson

Genese Dopson focuses her practice on the defense of companies in employment matters and in the defense of pharmaceutical and medical device manufacturers, as well as the defense of personal injury, insurance bad faith, employment and discrimination matters. She has successfully managed the defense of multi-plaintiff, multi-state litigation and has served as national coordinating counsel in pharmaceutical and medical device mass tort litigation. She is a former member of the editorial advisory board of MX Magazine, a publication that served the medical device industry.

Photo of Amy L. Baker Amy L. Baker

Amy Baker focuses her practice on product liability, medical device and pharmaceuticals litigation, and professional malpractice. She has experience in defending and prosecuting intellectual property litigation, including copyright, patent and trademark infringement along with related causes of action under state law. Amy enjoys handling technically challenging and complex litigation, and defending matters that are factually and procedurally intricate. Amy has successfully tried several cases to verdict on behalf of a variety of companies.