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.
The casual seller issue becomes even larger, the article surmises, where the source of the 3D printed product is a “hobbyist.” The same negligence/strict liability choice remains, depending on the size/sophistication of the seller. Id. at 617.
Our most interesting scenario is the third one – “Consumer 3-D Prints Products Designed by a Third Party,” id. at 617-19, because this is the closest that the article comes to a hospital printing a medical device to be used in a patient using software supplied by a non-manufacturing medical device company. The third fact pattern becomes “complicated” because the software designer “could be a recognized business entity, an individual, or even a group of identifiable or anonymous [open source] individuals.” Id. at 617. The article recognizes that claims against either the 3D printer maker, or the developer of the software “would have difficulties.” Id. Against the 3D printer manufacturer, the product liability element of defect at sale looms large, because even if the 3D printed product were defective, the defect could have originated in third-party software bought to operate the printer, well after the printer was sold. Id. at 618. A product liability suit against the software maker (assuming this entity is identifiable, as would be the case with medical devices) could well founder because, as we discussed in our prior post, computer code isn’t a “product” in any traditional sense. Software isn’t “tangible personal property,” unless “mass-marketed rather than customer-specific,” in which case some courts have declared them products. Id.
That mass-marketed software might be a product doesn’t advance a claim against the entity that made the 3D printer itself, but it would allow a separate strict liability claim against the software manufacturer. Id. That may turn out to be the case in medical devices, too, but maybe not, since 3D printed medical devices are designed to be “customer specific” – indeed much of the benefit from 3D printing of medical devices comes from just that type of customization, printing devices to fit the peculiar anatomy of an individual patient. The big problem identified by the article is anonymity, in that much 3D printing software is free and open source, meaning that “the author is hard to locate because the files are often edited and re-edited by multiple authors.” Id. That’s an interesting problem, but not one we expect to arise often in prescription medical product liability litigation.
The fourth scenario – where the consumer uses a scanner to create software that replicates a product that the consumer already owns, is the least plausible for liability. Consumers here are likely to be out of luck, since technology has enabled the consumer to be “effectively the manufacturer and potentially even the designer” of the resultant product. Id. at 619. Maybe the scanner manufacturer could become a defendant, but “[t}he law here is particularly unsettled and has the potential to leave consumers vulnerable to defective products without the ability to seek redress.” Id. A consumer becoming his/her own product manufacturer and designer may also become his/her own insurer as well.
The article, unlike many, does not seek a legislative fix, and that’s probably for the best, since legislation in so many areas dealing with computerized technology has become laughably outmoded very quickly. Article, 57 Ariz. L. Rev. at 619-20. “[B]right line rules” imposing liability have a tendency to be designed around and end up “inequitable.” Id. at 621. In the end, however, the article punts, which is a disappointing finish to an otherwise interesting read:
[A] flexible approach, which is most practicable through the courts, that evaluates each [defendant] on a case-by-case basis and takes into consideration the underlying principles for imposing strict liability would be more equitable to both the seller and the consumer. As a result, courts will often be best equipped to address legal issues raised by 3-D printing.
Id. Interestingly, the article views the FDA’s current 3D printing initiative for medical devices as promoting “meaningful industry involvement [that] is highly desirable in the realm of 3-D printing.” Id. at 622.
The Nielson article isn’t the seminal work on 3D printing and product liability that we’re looking for, but it’s at least a step in the right direction, recognizing how technology is scrambling the definitions that underpin strict liability.
The second article we’re recommending today is Bi (yes, that’s the entire surname), “What Is ‘False Or Misleading”’Off-Label Promotion?” 82 U. Chi. L. Rev. 975 (Spring 2015). We find this article interesting because it delineates an approach to off-label promotion that goes beyond the FDA’s meat-axe “we ban it” philosophy, rather than endorsing any particular result the article suggests in any particular case. We put this disclaimer up front because we disagree strongly with the article’s cartoonish descriptions – lifted from complaints – of a couple of incidents of alleged off-label promotion. See Id. at 997-76, 1021. The question posed, however, is a good one:
[H]ow to distinguish harmful off-label marketing from information that physicians find useful when making prescribing decisions[?] In particular, how should courts determine whether a physician’s reliance on off-label claims is the result of useful education as opposed to successful duping?
Id. at 976. Instead of the FDA’s flat ban, which the article recognizes faces significant constitutional hurdles, id. at 986-89, the article recommends applying “the framework for identifying false or misleading advertisements under the Lanham Act and the Federal Trade Commission Act.” Id. at 976-77. Since just about anything would be better than the corner the FDA has backed itself into, the article is worth a look.
Largely (we think) because of the FDA’s absolutist position, “courts have not yet addressed what constitutes ‘false or misleading’ off-label speech.” Id. at 977. The article spills a fair amount of ink on the FDA’s position, id. at 977-86. Because the FDA treats off-label promotion as “evad[ing] the regulatory process,” the Agency isn’t concerned with whether the promotion, itself, is true or false. Id. at 979. “Thus, under the FDA’s interpretation of the labeling provision, a drug is misbranded whenever a drug company intends that a drug be prescribed for an off-label use.” Id. at 981. This approach, the article recognizes has significant public health drawbacks:
Knowledge about new uses for a drug might emerge after the drug’s initial approval − particularly in heavily researched fields of medicine that are constantly evolving. Since doctors are free to prescribe drugs for both FDA-approved and unapproved uses, communication with drugmakers can allow doctors to obtain and use new research findings without waiting for the FDA to complete its lengthy approval process. Such off-label prescriptions can have tangible public health benefits–the medical community considers some off-label uses to be “state of the art” procedures for treating certain conditions.
Id. at 984 (as always with law review articles, footnotes omitted). The result is censorship, or self-censorship, of off-label information by FDA-regulated manufacturers:
[I]t is clear that the FDA holds drugmakers to a higher standard than mere truthfulness. . . . [A] claim . . . is misleading if it is based on a clinical study that would not meet the specific requirements of the FDA . . . even if the research results were overwhelmingly persuasive or accompanied by a disclaimer.
However, . . .the exact standard for what constitutes acceptable off-label communication is unclear. Drug companies that wish to minimize their chance of facing an FDA enforcement action thus have an incentive to withhold information about uses that are not yet supported by studies conducted in accordance with FDA best practices.
This uncertainty is problematic because it impedes the very off-label communications that are most valuable to the development of medical science.
Id. at 984-85.
Change is likely to come. Look out, FDA, the First Amendment is after you. “The drugmakers’ free speech argument has recently gained traction.” Article, 82 U. Chi. L. Rev. at 987. We won’t go into the First Amendment discussion in the article, since we’ve said it all before. Suffice it to say that “many commentators agree” that we’re on our way “to a safe harbor for truthful off-label promotional speech” because “the FDCA does not prohibit truthful, nonmisleading off-label promotion.” Id. at 989.
Thus, the thesis of the article is that everyone – the FDA, courts, and litigants, should move the debate over off-label promotion to creating a workable definition of “false or misleading” information about off-label uses. Since the FDA uses a Big Brother approach that defines truth as false, its “regulations are not, on their own, sufficient.” Id. at 991. The Article looks instead to precedent under the Federal Trade Commission Act and the Lanham Act for guidance. If you’re interested in details and rationale, by all means read the article. We’ll play spoiler and jump directly to the bottom line:
[F]alse or misleading off-label speech compromises patient health and safety only if it interferes with physicians’ prescribing decisions. Thus, the effect of off-label speech on physicians’ ability to make informed prescribing decisions is an appropriate metric for distinguishing false or misleading off-label speech from potentially valuable communication. . . . [A]n off-label statement is false or misleading if it leads a reasonable physician to make a different prescribing decision than she would otherwise have made in the face of complete and accurate information about the promoted prescription drug.
Id. at 998. The Article goes on to explain the basis for this definition and the perceived “benefits” (“normative” and otherwise) that would be gained from adopting it. Id. at 1000-05. It contains a detailed element-by-element analysis of how a “false or misleading” standard for off-label promotion could work. Id. at 1006-20. While we could quibble with this or that sub-argument, we have to admit that this framework is far more productive of reasoned results than the barren “thou shalt not” approach of the FDA.
Which brings us to consider why we have consistently advocated free speech for off-label use since the moment we started the blog. The reason is simple. Regardless of the Article’s suspicion (born, we think, of reading too many overly prolix complaints and overly terse answers) that there is significant “false” or “misleading” off-label promotion going on, we don’t think there is. Industry isn’t perfect by any means, but requiring proof of actual falsity in off-label information should greatly reduce the amount of litigation over off-label promotion because there won’t be than much left to fight about. We believe that the great majority of off-label promotion that goes on is both truthful and helpful to physicians and their patients and we would welcome a standard that would allow manufacturers to prove that.