We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing” and “design” of products.  With respect to medical devices, if an implant is custom produced from equipment owned by, and located at, the hospital where the surgery is conducted, who’s the manufacturer for product liability purposes if, say, the implant fails in some way?  Our prior post provided some legal analogies that we thought might be useful.  We didn’t claim to be comprehensive or conclusive.

It’s a “wild, wild west” legal issue, so we were predictably intrigued when the law review article, Park, “For A New Heart, Just Click Print:  The Effect on Medical & Products Liability from 3-D Printed Organs,” 2015 U. Ill. J.L. Tech. & Pol’y 187 (Spring 2015), showed up on several of the half-dozen or so searches we run to stay current in our field.  Continuing with our “we read law review articles so our readers don’t have to” philosophy, we took a look.

We were disappointed, not particularly by its pro-plaintiff tone (we’re used to that from the academy), but by its superficiality.  Unfortunately, the article doesn’t seem to “get” the true legal complexities of 3D printing.  From beginning to end, it remains mired in the traditional paradigm – a prescription medical product produced by a “manufacturer” who provides warnings to the treating/implanting physician under the learned intermediary rule.  The paradigm shift that 3D printing promises, the devolution of the manufacturing function to on-site locations neither owned nor controlled by traditional Restatement of Torts “manufacturers,” goes totally unaddressed.

Maybe we were expecting too much.  It’s a student, rather than a professorial, article.  The best part of this article is its factual discussion of 3D printing in the field of medical devices.  “New Heart,” 2015 U. Ill. J.L. Tech. & Pol’y at 189-93.  These sections seem pretty current in the research and cite lots of interesting stuff, collecting it in one place.  Unfortunately, it’s largely downhill from there.  The article focuses in the most complex form of 3D printed medical device – artificial organs – and treats that in an utterly pedestrian manner.

We waded through a wholly unnecessary discussion of organ donation regulation, which is presented as some sort of alternative to the FDA.  We’ve been around long enough that it’s blindingly obvious to us that 3D printing of medical devices (and drugs, which the article does not consider at all) is and will be subject to extensive FDA oversight.  Thus, we think that the organ donation alternative discussed, and properly discarded, by the article (2015 U. Ill. J.L. Tech. & Pol’y at 193-95, 198-99) is a makeweight issue not worth the time spent on it.Continue Reading Unfortunately Disappointing 3D Printing Law Review Article