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.
Conversely, the article’s discussion of FDA regulation, id. at 195-97, is underpowered, not adequately addressing clinical investigations and modern post-marketing issues, such as REMS and the FDA’s Sentinel system. Rather, the discussion is limited to the dichotomy found in Supreme Court preemption cases (the article has an entire section, id. at 196-97 on Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)) between §510k “substantial equivalence” clearance and premarket approval. To us that’s another false conflict. Device clearance under §510k is only available to devices “substantially equivalent” to those already on the market, usually going back to the 1976 (not 1975, as the article states) date of the statutory amendments that originally gave FDA authority over medical devices.
Once again, it’s blindingly obvious that 3D printed artificial organs (whether or not built from a biodegradable scaffold) aren’t “substantially equivalent” to anything that went before. Of course they will be pre-market approved devices, unless Congress steps in to create something altogether new, which is always possible. While some 3D printed devices (sized components of metal implants, come to mind) may fall within §510k, replacement organs are, almost by definition, life sustaining, and thus have to be PMA.
After these two straw men are knocked down, 2015 U. Ill. J.L. Tech. & Pol’y at 198-201, the article moves on to PMA preemption under Riegel. It treats preemption mostly as a “how can we get past it” proposition, spending practically no time on why preemption exists in the first place, and lots of time on the existing/arguable exceptions to preemption. The 3D printing context, unfortunately, receives only cursory attention. Parallel claims are mentioned (id. at 201-03), but without any discussion of what types of FDA regulations are/are likely to be applicable to 3D printing in particular. For example, dispersal of many manufacturing activities to numerous end users alone will require a huge change in FDA practice, since under current law each manufacturing “facility” is subject to registration, inspection, etc. The FDA can’t possibly keep that up when every hospital has a 3D printer creating bespoke medical devices. Not all 3D printed devices require dispersed production, but many will – and that’s precisely what makes this legal subject so interesting.
The article likes to cite Bausch discussed by us here), which involved parallel claims based on purported GMP violations, but omits what would be really interesting to read about – what kinds of GMPs are likely to be applicable to 3D printed medical devices, and thus possibly at issue in asserted parallel claims involving these devices? Will there even be Forms 483?
The purpose of law review articles – indeed, of most academic articles – is to synergize, to tell the reader something s/he doesn’t already know. That’s where this article falls down. It fails to extrapolate from the existing cases, all of which involve much different facts than would exist for 3D printed devices. 3D printing presents all kinds of fascinating scenarios, but they’re not in this article.
Take another example. The article spends all of three sentences on claims “against the representative of the manufacturer who provided the medical device to the physician.” 2015 U. Ill. J.L. Tech. & Pol’y at 201. Yes, the FDA “does not regulate,” id., those interactions, so preemption is in question. But with 3D printing, manufacturers in a lot of cases won’t be providing devices at all. Many such products will be created in hospitals (some already are), custom-fit according to information drawn from patient-specific scans. The software that interprets these scans and tells the printer what to do will come from one (FDA regulated) source, the printer itself will probably come from somebody else (likely FDA regulated), the raw material from yet another source (maybe FDA regulated), and actual production will take place in the hospital where the surgery is to be performed (not FDA regulated). There are all kinds of potential interactions here, with potential (or not) for liability. Not only does the article not discuss any of these; it never even acknowledges that they exist. These variables are precisely how 3D printing is most likely to scramble product liability.
The article also discusses pharmacovigilence (or whatever the device-specific equivalent term would be), but again solely in the context of an exception to preemption. 2015 U. Ill. J.L. Tech. & Pol’y at 204-05. Even there, how a law review discussion of “whether preemption would apply to common law claims when the manufacturers deceived the FDA,” id. at 204, can occur without citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), even once is beyond us – and not just because of Bexis’ involvement in Buckman. A Supreme Court decision mandating preemption of “fraud on the FDA” claims seems directly on point.
Beyond that rather glaring omission, the article states that 3D printed organs are “years from becoming a reality.” 2015 U. Ill. J.L. Tech. & Pol’y at 188. We agree. As we’ve discussed in more detail here, the failure-to-report decisions that the article does discuss aren’t likely to be of any use by then, since the FDA is currently transitioning from affirmative reporting systems (voluntary or otherwise) to “big data” crunching of information derived from millions of electronic medical records (its “Sentinel” system). By the time that 3D printed organs have shed their investigational status, the kind of post-marketing claims addressed by the article in all likelihood won’t even be relevant. Once again, we find ourselves wishing that this article had displayed a little more of what a former president once called “the vision thing.”
Finally, the article discusses “good old negligence” – that is to say, malpractice – claims against physicians who will be implanting 3D printed organs. 2015 U. Ill. J.L. Tech. & Pol’y at 206-08, 210. Yes, those claims will exist, as they do with respect to every other aspect of medical practice. But what will they look like? The article calls that “speculative,” id. at 206, but isn’t that exactly what readers are interested in? 3D printing involves software. How much back-end testing of 3D printing software is properly held within the medical standard of care? To what extent must implanting physicians become engineers? We don’t know. The article hardly discusses the standard of care; focusing instead on state-by-state regulation of organ donation.
Nor does the article address the other relevant aspect of medical practice – informed consent. Instead it discusses the “learned intermediary doctrine.” Id. at 207-08. These aren’t the same thing, and only informed consent is a cause of action against physicians. 3D printed organs will “go through clinical trials and a review process that could take from three to ten years.” Id. at 208. During that time, these products will be considered “investigational” and subject to detailed FDA informed consent regulations pertaining to clinical trials. See 21 C.F.R. Part 50. None of this is discussed in the article.
We come away from this article badly disappointed. The product liability implications of 3D printing is a great topic for law review articles, and we had hoped when we saw the title that this article would be one of them. It wasn’t. The fundamental issue that 3D printing poses – what happens to product liability law when users become manufacturers? – wasn’t even faced here. Please try again. 3D printing is now where off-label use was in the late 1990s, waiting for somebody to pen (or type) the seminal article.