This guest post is by Reed Smith‘s Matthew Jacobson.  It discusses the FDA’s recent guidance on the hot topic of 3D printing as a manufacturing practice for regulated drugs and medical devices, but not biologics (at least not yet).  As always with our guest posts the author is 100% responsible for the content.

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A lot has happened over the past 19 months, some good, some bad, and some just unbelievable. To name a few, and without sounding like a remake of We Didn’t’ Start the Fire, a total solar eclipse, a new human organ was discovered, Brexit, another royal engagement, the Patriots had the largest comeback in Super Bowl history, fourteen top-level people have “left” the presidential administration (not counting the entire Obama administration), Tim Tam’s became available in the U.S., and Bexis and I wrote the most comprehensive law review article to date on the product liability implications of 3D printing.

And as we prepare to head into 2018, the U.S. Food and Drug Administration (FDA) gave us another headline releasing its guidance for Technical Considerations for Additive Manufactured Medical Devices and issuing a statement from FDA Commissioner Scott Gottlieb M.D. on a “new era of 3D printing of medical products.”  For those daily readers, you may remember that we first reported on the guidance when it was in its draft form in May 2016—19 months ago. In that time, FDA has been evaluating comments and feedback provided by entities in the 3D printing industry. The final guidance is, as you may expect, substantively similar to its draft form. As we see it, that is good news, that the new administration’s approach on 3D printing of medical devices is the same as the old—which is rare these days.

The FDA Commissioner says the agency has reviewed more than 100 medical devices and one drug that are currently on the market, which are being manufactured by 3D printers.  He goes on to say that the “FDA is now preparing for a significant wave of new technologies” and that the FDA is “working to provide a more comprehensive regulatory pathway that keeps pace with those advances, and helps facilitate efficient access to safe and effective innovations that are based on these technologies.”  That regulatory framework will need to adjust how “existing laws and regulations that govern device manufacturing [apply] to non-traditional manufacturers like medical facilities and academic institutions that create 3D-printed personalized devices for specific patients they are treating”—in other words, point of treatment device fabrication.  The FDA is also researching the technology itself, has its own 3D printing labs and is providing opportunities for “innovative approaches to pharmaceutical product design or manufacturing, including additive manufacturing of pharmaceuticals.”  In fact, according to the statement “[m]ore than a dozen pharmaceutical manufacturers have formally or informally been in contact with [the FDA’s Center for Drug Evaluation and Research] regarding the use of 3D printing to manufacture drugs.”

The guidance, according to the FDA, is intended to provide FDA’s thoughts on 3D printing and is meant to evolve as the technology grows.  As was its draft version, it is still split up into two categories of considerations: 1) design and manufacturing and 2) device testing.  Both sections overlap in substance, and the device testing section in particular provides strong, detailed recommendations for what a device manufacturer should include in a premarket submission for a device that uses additive manufacturing as a manufacturing technique.

Some noteworthy additions to the draft guidance (we are not repeating what we said then) that us non-technical folks noticed in the latest guidance are:

    • The final guidance adds that patient-matched devices (devices that are based on or “matched” to a specific patient’s anatomy, usually based on medical imaging data) are especially vulnerable to file conversion errors because “anatomic curves are typically geometrically or mathematically complex, which can create difficulties when calculating conversions.”
    • The guidance also adds a section on cybersecurity and privacy related to protecting personally identifiable information and protected health information, which can be an issue for patient-matched devices.
    • Establishing control limits to make sure that a product meets all predetermined requirements when it is “printed.”
    • Pointing out that use of workflow that automates one or more software steps should be considered.
    • Adding to the “Material Controls” section materials of animal origin and composite materials

For the most part it appears the guidance’s changes, some of which we noted above, focused on the different types of 3D printers that are available and each printer’s unique characteristics, which may vary from brand to brand and with the type of material used. The guidance also seems to focus more on providing examples rather than trying to be all inclusive, which will allow for the technology to develop, without the need for the guidance to be updated.

We have been waiting a while for this final guidance to be released. Unfortunately, we may have to wait even longer for the FDA to release a guidance on the truly novel medical devices, which are 3D printed with biomaterials, such as stem-cells.  Dr. Gottlieb says that the FDA “envision[s] that burn patients in the near future will be treated with their own new skin cells that are 3D printed directly onto their burn wounds” and “the potential for this same technology to eventually be used to develop replacement organs.”  However, based on the timing of the FDA’s past communications with 3D printing, it may be longer than 19 months this time. Who knows, by then we may be dealing with the FDA’s position on 3D printing under the Rock’s presidency.

As our loyal readers know, the Reed Smith side of the blog has been very interested in 3D printing, and particularly in its product liability implications. We recently shared with you the most comprehensive law review article to date on this subject (here) – authored by Bexis and Reed Smith associate (and sometimes guest blogger) Matt Jacobson – and we have posted about 3D printing here, here, here and here.

If you’ve found yourself equally fascinated by this new technology – and its potential impact on life sciences product liability – we’re pleased to announce that Bexis and Matt will be presenting a free 60-minute webinar on “3D Printing: What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers” on May 8 at 12 p.m. ET.

This webinar is presumptively approved for 1.0 general CLE credit in California, Illinois, New Jersey, Pennsylvania, Texas and West Virginia. For lawyers licensed in New York, this course is eligible for 1.0 credit under New York’s Approved Jurisdiction Policy.

The program is free and open to anyone interested in tuning in, but you do have to sign up, which you can do here.

 

This post is from the Reed Smith side of the blog only.

For well over a year, now Reed Smith has been engaged in an “initiative” concerning the innovative technology, “3D printing,” also known as “additive manufacturing.”  We’ve tried to stay on the forefront of the legal implications of 3D printing, particularly the product liability implications, as we have posted about it here, here, here and here.

Blogging is a quick way to disseminate information, but it’s not the only way.  That’s why Bexis, sometimes guest poster Matt Jacobson, and a number of their Reed Smith colleagues have explored the legal ramifications of 3D printing in a more in-depth and traditional fashion.

Most recently, Bexis and Matt have authored the most comprehensive law review article to date on the product liability implications of 3D printing.  The article is called, “3D Printing:  What Could Happen to Products Liability When Users (and Everyone Else in Between) Become Manufacturers,” and it will appear in the Minnesota Journal of Law, Science & Technology at 18 Minn. J.L. Sci. & Tech. 143 (2017).  If there is anything better out there on this subject, we have not seen it.  It’s now on the law review’s site, and you can download directly a PDF of the article for free at this link.

The first part of this comprehensive article covers the nature of 3D printing and how this new technology works.  There follows an overview of traditional tort liability concepts, and of the gray area that occurs when a potentially revolutionary new technology that allows anyone to become a manufacturer meets legal doctrines, like strict liability and warranty, that turn on concepts like “manufacturer” and “seller” from a prior era.  The second part of the article focuses specifically on 3D printing’s impact on medical devices and health care and the product liability considerations that are specific to these highly technical and potentially life-saving products.

As 3D printing appears to be the next great chapter in the industrial revolution, with the technology often moving more rapidly than the law, this article is significant in that it comprehensively analyzes the current state of products liability law and the legal issues that arise from this body of law when 3D printing is involved.

Second, Reed Smith, again with Bexis and Matt co-authoring the tort liability chapter, has now released a second edition of its “white paper” on 3D printing legal issues:  “3D Printing of Manufactured Goods: An Updated Analysis.”  The paper includes chapters on the following topics:  (1) Constitutional Issues (regarding 3D printed guns); (2) Commercial Litigation; (3) Product Liability, (4) 3D Printing/Component Parts/Raw Materials, (5) Insurance Issues, (6) Intellectual Property Issues, (7) Data Privacy, and (8) Environmental Safety.

The second edition of the Reed Smith 3D printing white paper is available here. And for those who missed the first edition, it can be found here.

We on the Reed Smith side are committed to exploring this novel technology and the legal issues that come with it, especially when those issues involve products liability.  We will continue to post any new updates as products liability law changes (or does not change) as 3D printed products become more and more commonplace.

Another guest post today, this one by Reed Smith’s Matt Jacobson and Kevin Madagan on the draft guidance document released earlier this week by the FDA. With the 3D printing of medical devices at the forefront of the burgeoning additive manufacturing revolution − and inevitably to become the target, eventually, of product liability litigation – anything the FDA does to move the ball forward (or not) is of great interest.

As always, our guest blogger deserves all the credit (and any blame) for what follows. Take it away Matt.

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The blog is not a stranger to 3D printing, the cooler and slang term for the additive manufacturing process. See here, here, here, and here.

The U.S. Food and Drug Administration (FDA) is not a stranger to 3D printing either. It has already approved more than 80 medical devices and one prescription drug that are produced by 3D printing techniques. It also held a public workshop to obtain information and input about 3D printing issues on October 8 and 9, 2014. FDA brought together technical 3D printing expertise from various industries and sectors to help the agency develop an evaluation process for future submissions of medical devices resulting from additive manufacturing techniques. After the workshop, FDA was silent on 3D printing, well that is, until last Tuesday, when it released a draft guidance for Technical Considerations for Additive Manufactured Devices.

Although the FDA workshop was almost a year-and-a-half ago, it was not for nothing, as the draft guidance is based on the feedback from the workshop. According to FDA, the draft guidance is a “leap-frog” guidance to share FDA’s “initial thoughts regarding technologies that are likely to be of public health importance early in product development.” While the draft guidance is not meant to be a comprehensive document to address all regulatory requirements, it highlights the technical considerations and recommendations for design, manufacturing, and testing of medical devices that include at least one fabrication step using additive manufacturing.

FDA is careful to warn that the guidance does not apply to any devices that use bioprinting − incorporating biological, cellular, or tissue-based products into the additive manufacturing process.

Continue Reading Guest Post – Highlights of FDA Draft Guidance on 3D Printing

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.

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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, here, and here.  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.

Continue Reading Guest Post – First Contact – 3D Printing Meets the Learned Intermediary Rule

On this Friday afternoon, we thought we’d let our readers know about a couple of other drug/device-related irons that members of your blogging team have in the fire right now.

First, as you know, we’ve been interested in the innovative potential of 3D printing – particularly of medical devices, but drugs, too.  Our posts on the potentially disruptive effects of 3D printing on traditional product liability categories are available here.

Reed Smith, with Bexis co-authoring the tort liability chapter, has now released the most extensive “white paper” on 3D printing legal issues that we’ve seen to date.  If there’s anything better out there, we haven’t seen it.  It’s called “3D Printing of Medical Devices: When a Novel Technology Meets Traditional Legal Principles,” and it has chapters on the following topics.  (1) Regulatory Issues, (2) Intellectual Property, (3) Tort Liability, (4) Environmental Effects and Health Risks in the Work Place, (5) Insurance Issues, (6) Reimbursement, and (7) Litigation.  Those of us on the Reed Smith side are committed to keeping this white paper current in light of new developments in this fast moving field.  Medical devices have been ahead of drugs in adopting the novel technology, but we expect we’ll cover the latter as they develop as well.

Like the blog, the Reed Smith 3D printing white paper is free to all comers.  A more detailed description can be found here, and the whole white paper is available here.

Second, the Dechert side of the blog – Michelle Yeary – is co-chairing a conference called “Drug and Device Defense − Emerging Litigation & Regulatory Developments.”  Also participating is  as well a former Dechert blogger Will Sachse.  Unlike the blog, this conference is only open to the folks on our side, being billed as a “defense-only conference on drug and device litigation and regulation.”  That means the presenters will be able to discuss things that we don’t talk about on the blog because we don’t want to give the other side any bright ideas.

The topics at Michelle’s conference include:  (1) The relationship between in-house and outside counsel; (2) Developments relating to labeling and promotion of brands and generics; (3) Best practices in handling government investigations; (4) State of mass tort litigation today; (5) Matters to watch in 2016 and beyond; (6) Emerging issues such as 3D printing of medical devices; and (7) Ethical issues for lawyers in litigation.

If you’re interested in this conference, you can sign up here.  Unlike the blog, it isn’t free (except to in-house types), but rather costs $795.  The conference will occur on October 20, 2015, all day from 8:30 through 5:30, at the Hub Cira Center in Philadelphia at 2929 Arch St. − that’s the shiny glass building behind the 30th Street train station.

The last couple of times we’ve commented on new law review articles, we haven’t liked what we’ve seen very much.  We’re gluttons for punishment, however, and this time we were rewarded.  We found a couple of recent law review articles that we think were actually worth the effort.

The first of these comes from our quest for enlightenment regarding 3D printing – which is already making an impact in the medical device market.  Aside from our own prior thoughts, we had not come across anything that we considered a serious analysis of the product liability possibilities when the user (or someone else farther along in the supply chain) also becomes the manufacturer of the product.  That changed with Heidi Nielson, “Manufacturing Consumer Protection for 3-D Printed Products, 57 Ariz.L. Rev. 609 (2015).  This article notes the various ways in which 3D printed products can reach the consumer:  (1) They could be manufactured and sold in the traditional way, with the consumer ordering a 3D printed product from a manufacturer or retailer; (2) a “hobbyist” (casual seller) sells a 3D printed product of his/her own design to a consumer (again, relatively traditional, but raising “deep pocket” concerns); (3) the consumer buys/downloads open source software and produces the product from the consumer’s own 3D printer; (4) the consumer, using acquired software, scans an existing product, creates his/her own printable file and then reprints the product from his/her own 3D printer (which could become typical for replacement parts).  Article, 57 Ariz. L. Rev. at 614-15.  This list already shows some serious thought.

The section on “Liability for Defective 3-D Printed Product” continues with the kind of discussion we’ve been hoping for.  In the first variant, it’s pretty traditional, except to the extent that a seller of 3D printed products claims to sell 3D printing “services” instead of products.  Such sellers “may attempt to contract out of liability for defects and instead hold CAD-file designers responsible.”  Id. at 616.  The article states that “independent designers of products are generally not held strictly liable for defects in their designs, but may be liable for negligence in their designs.”  Id. (citing law review article).  The casual seller problem is also noted.  Id. The bottom line (according to the article) is that small-scale sellers of 3D printed products would be subject to negligence, and larger-scale sellers subject to strict liability.  Id.

Continue Reading A Couple of Law Review Articles We Actually Like

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

The other day we read a thoughtful Bloomberg piece on 3D printing in the medical device context by a trio of Alston & Bird litigators.  We’ve given you the link, but it might be behind a paywall.

The article indicates that 3D printing of medical devices is already a reality.  3D printing is currently being used with implants where sizing is both critical and extremely patient specific – the article mentions tracheal splints, skull plates, hip cups, spinal cages, knee trays, and dental reconstruction devices. Here’s a cool slide show that we found on the FDA’s website showing some of them and discussing relevant 3D printing techniques.  Also according to the article, the FDA doesn’t have any specific 3D printing guidance available – which we confirmed on Westlaw (no mention of “3D printing” or “additive manufacturing” in any FDA guidance).

Continue Reading Some Ideas About 3D Printing