A Glimpse into How Courts Will Treat 3D Printed Medical Devices

Here is a guest post on an interesting case.  It’s the first decision that we’re aware of in which a 3D printed medical device (or any 3D printed product) has been the subject of litigation that involves product liability principles.  This post is submitted by Matt Jacobson of Reed Smith, who is particularly interested in 3D printing issues.   As always our guest blogger gets all the credit, and any blame, for the analysis that follows.


October 21, 2015, the day Marty McFly, Doc, and their flux capacitor-charged Delorean arrived in the future.  The future was filed with flat screen TVs, self-lacing shoes, flying cars, cold fusion, Pepsi Perfect, and, of course, hover boards.  While the future is only a week away now, in the 1980s, when Back to the Future, Part II hit movie theaters, it seemed like a long way off.   However, a surprising amount of Back to the Future tech and non-tech (the Cubs are in the playoffs after all) are now part of our everyday lives—flying cars and cold fusion, not so much.  One thing, the movie did not predict was 3D printing.  3D printing is turning science fiction into reality, and as the technology continues to develop, we may soon realize the future really is here.

This blog is not a stranger to 3D printing, as we have posted about it here and below.  But as the writers of Back to the Future could not actually predict the future, neither can we predict how courts will handle 3D printed medical devices.   A glimpse into that future may be found in Buckley v. Align Technology, Inc., No. 5:13-cv-02812-EJD, 2015 U.S. Dist. LEXIS 133388 (N.D. Cal. Sept 29, 2015)—which, as far as we can find, is the first even semi-product liability case dealing with a 3D printed product.

The 3D printed product is Invisalign braces, which are a series of custom-made aligners that are used to treat misalignment of teeth (or the technical term malocclusion).  Invisalign braces are only available through a prescription by a dentist.

Plaintiff alleged that her dentist took dental impressions of her teeth who sent them to Align (the company that markets and sells Invisalign) to be evaluated and approved.  Align then 3D printed the aligners for plaintiff.  After wearing the aligners for almost 2 years, her malocclusion, which was caused by worn down teeth, did not improve.  Plaintiff filed a complaint against Align centered on the allegation that “Align falsely advertised, misled and deceived her and other consumers into believing that the Invisalign aligners could treat their malocclusions.”  Id. at *3. Read more

Source: jdsupra.com

Leave a Reply

Your email address will not be published.