Defense Counsel Journal
3D Printing: Product Liability, Professional Liability and Other Tort Aspects of the Burgeoning Industry
Volume 87, No. 2
April 29, 2020
Product Liability
Jordan Lipp
Jordan Lipp
Jordan Lipp is a managing member at Childs McCune, LLC in Denver, Colorado. He wrote the book on product liability law in Colorado – Jordan Lipp, Product Liability Law & Procedure in Colorado, Second Edition (CBA-CLE Books 2019). He has successfully defended some of the largest jury trial product liability and catastrophic injury cases in Colorado, and his practice includes product liability defense, outdoor industry/ski area defense, and complex commercial litigation. Jordan is also an adjunct law professor at University of Denver’s Sturm College of Law. The author wishes to thank his colleagues Mark A. Fogg and Corinne C. Miller for their input and guidance on this article.
Steven Michalek
Steven Michalek
Steven Michalek is a managing member at Childs McCune, LLC in Denver, Colorado. He has been representing health care providers in medical malpractice, licensing board, and risk management matters for over 20 years.
AT THE dentist’s office in the space of one visit, a dentist today can examine a patient, scan the patient’s broken tooth, use computer mapping technology and 3D printing technology to create a crown, and then cement the crown onto the patient’s tooth. This remarkable and efficient process was unheard of not too long ago, but now is common practice.
The burgeoning use of 3D printing, however, raises a host of liability issues. If the patient has an alleged complication related to the creation and placement of the crown, he or she may decide to sue the dentist. In such a circumstance, is this lawsuit based upon product liability law as the dentist manufactured and sold the allegedly defective product? Or, is the lawsuit based upon professional negligence law as the dentist is performing a dental procedure? And, what about the potential liability of the manufacturer of the 3D printer itself, the liability of the software company whose software was used to create the crown, and the liability of the manufacturer of the material used to make the crown?
This article will explore the legal ramifications of this emerging technology and some approaches to defending these lawsuits. Although 3D printing is being used in a myriad of industries, including architecture, automotive, food, and medical device, there is still a dearth of published case law on personal injury litigation involving 3D printed products. Cases involving 3D printed products face novel issues, which differ from those involving traditional products. This is due to manufacturing no longer being confined to the realm of large industrial plants. Rather, individuals (such as architects, chefs, dentists, doctors, engineers, etc.) can now arguably be the manufacturers of products themselves.
I. Background on 3D Printing and Its Use in the Courtroom
Before addressing the liability implications of 3D printing, some background on 3D printing is warranted. 3D printing has been around for several decades,1See Coene v. 3M Co., No. 10-CV-6546-FPG, 2017 U.S. Dist. LEXIS 39486, at *2-3, 2017 WL 1046749 (W.D.N.Y. Mar. 20, 2017).
but only achieved widespread use in the past decade. “3D printing is a process whereby three-dimensional solid objects are created through a process called additive manufacturing.”2Barranco v. 3D Sys. Corp., 307 F. Supp.3d 1075, 1080 (D. Haw. 2018).
A 3D printer builds the product one layer at a time based upon a computer-aided design model, often by using a laser to “turn layers of powdered material into a three-dimensional solid object by sintering only particular areas of each layer of the powder, binding that area of the material together and creating the finished product as more layers of powder are added and sintered.”3Coene, 2017 U.S. Dist. LEXIS 39486, at *2-4.
3D printing differs from the traditional and historical method of manufacturing, the “subtractive” manufacturing process. Subtractive manufacturing is the process “in which a final part is formed by subtracting from a solid block of material, through cutting, grinding, or other subtractive processes.”4Barranco, 307 F. Supp.3d at 1080.
Many litigators are already familiar with 3D printed products from their use in the courtroom. 3D printing is already becoming ubiquitous in creating exhibits, especially demonstrative exhibits. Interestingly, the court decisions that have addressed such 3D printed exhibits have analyzed their use and admissibility in the same manner as any other exhibits.5Williams v. Manitowoc Cranes, LLC, No. 1:14CV383-HSO-JCG, 2016 U.S. Dist. LEXIS 188539, 2016 WL 7670061 (S.D. Miss. Sep. 21, 2016) (rejecting expert’s use of a 3D printed alternative design barrier because the barrier was not for demonstrative purposes but rather for scale-model testing that the Court ruled was impermissible); United States v. Scott, No. 3:14-cr-00060-BLW, 2015 U.S. Dist. LEXIS 57748, at *2-4, 2015 WL 2036331 (D. Idaho Apr. 30, 2015) (permitting the use of two 3D printed skull demonstrative exhibits replicating the victim’s skull at a murder trial).
Put another way, whether the exhibit was created by using additive manufacturing or subtractive manufacturing has not had any impact as of yet on a Court’s ruling of admissibility.6Scott, 2015 U.S. Dist. LEXIS 57748, at *2-4.
There are some product liability cases involving allegations of the 3D printer itself causing injury as opposed to the products created by the 3D printer causing injury.7Ferguson v. Concept Laser, GmbH, Civil Action No. 14-cv-12835-ADB, 2016 U.S. Dist. LEXIS 54833, at *2 (D. Mass. Apr. 25, 2016) (alleging a 3D printer exploded); cf. Coene, 2017 U.S. Dist. LEXIS 39486, at *1 (alleging worker using 3D printing at a factory contracted lung disease from the materials used to print the products).
However, as 3D printing technology becomes more widespread, it is likely that there will be more lawsuits with allegations of defective products made by 3D printers. This leads to the “elephant in the room” question of the applicability of product liability law to such 3D printed products.
II. Product Liability Claims against Professionals Using 3D Printing Devices
Most states have adopted strict liability in the context of lawsuits involving allegedly defective products. As the Restatement (Second) of Torts explains, sellers of “products” that are “in a defective condition unreasonably dangerous to the user” can be held strictly liable.8Restatement (Second) of Torts § 402A(1) (1965).
There are three categories of product defects – products that are allegedly (i) defective in design, (ii) defective in manufacture, or (iii) defective in warnings or instructions.9See Bruesewitz v. Wyeth LLC, 131 S.Ct. 1068, 1076 (2011) (“Products-liability law establishes a classic and well-known triumvirate of grounds for liability: defective manufacture, inadequate directions or warnings, and defective design.”).
As a general matter, strict liability claims are more challenging to defend than negligence claims. As such, eliminating strict liability claims is a common goal by defense counsel when appropriate.
With regard to defending strict liability claims involving 3D printed products, two questions immediately arise. First, does the 3D printed product fit within the definition of a “product” under product liability law? Second, is the professional who printed the product a seller / manufacturer of the product? Each issue is addressed in turn below. Then, other defenses and insurance issues are discussed.
A. Is a 3D Printed Product a Product?
While the widely adopted Restatement (Second) of Torts § 402A does not define the term “product,” the Restatement (Third) of Torts: Product Liability defines a “product” as “tangible personal property distributed commercially for use or consumption.”10Restatement (Third) of Torts: Products Liability, § 19(a) (1998).
As such, a product subject to product liability law is typically a “mass-produced” product.11See id. cmt. e; accord Oliver v. Superior Court, 211 Cal. App. 3d 86, 87-89, 259 Cal. Rptr. 160, 161-162 (Cal. App. Ct. 1989); see also Restatement (Second) of Torts, § 402A, cmt f (1965).
Depending upon the facts of a case, a professional who prints 3D items may be able to argue that his or her 3D printed product is not a “mass-produced” product, and as such may not be subject to product liability laws.
Similarly, services are not products.12Restatement (Third) of Torts: Products Liability, § 19(b) (1998).
In the dentist example at the start of this article, the dentist is providing a combination of services and the 3D printed product, i.e., the crown. The demarcation between whether this constitutes a sale or service is a not an easy question to answer, and it is difficult to predict how each court will address the issue.13See Restatement (Third) of Torts: Products Liability, § 20, cmt. d (1998) (“When the same person provides both products and services in a commercial transaction, whether a product has been sold may be difficult to determine.”).
Interestingly, “in a strong majority of jurisdictions, hospitals are held not to be sellers of products they supply in connection with the provision of medical care, regardless of the circumstances.”14Id.
Defense counsel should explore whether the 3D printed product actually falls within the “service” as opposed to the “product” category.
B. Is the Professional Who Prints the Product a Seller or Manufacturer?
Assuming the 3D printed product is found to be a product under product liability law, the next question is whether the professional is the proper defendant in a product liability action. Product liability law is generally confined to claims against a manufacturer or a seller.15See Restatement (Second) of Torts § 402A (1965); see also Restatement (Third) of Torts: Products Liability, § 20, cmt. d (1998).
This begs the question, is the individual dentist (or architect or engineer) who specifies the details of the product to be printed by the 3D printer the manufacturer or the seller?
As a general matter, people who occasionally sell a product or products likely do not fall within the gambit of product liability law and strict liability. On the other hand, people who are in the business of supplying products do fall within the gambit of product liability law and strict liability. As the Restatement (Second) of Torts explains:
The rule [of strict liability] does not, however, apply to the occasional seller of food or other such products who is not engaged in that activity as a part of his business. Thus, it does not apply to the housewife who, on one occasion, sells to her neighbor a jar of jam or a pound of sugar. Nor does it apply to the owner of an automobile who, on one occasion, sells it to his neighbor, or even sells it to a dealer in used cars, and this even though he is fully aware that the dealer plans to resell it. The basis for the rule is the ancient one of the special responsibility for the safety of the public undertaken by one who enters into the business of supplying human beings with products which may endanger the safety of their persons and property, and the forced reliance upon that undertaking on the part of those who purchase such goods. This basis is lacking in the case of the ordinary individual who makes the isolated sale, and he is not liable to a third person, or even to his buyer, in the absence of his negligence.16Restatement (Second) of Torts, § 402A, cmt f (1965).
Although written over fifty years ago when the concept of 3D printing would have seemed like pure science fiction, the Restatement’s language may well provide guidance on whether a product liability claim can proceed against a professional who uses a 3D printer to print products regularly or occasionally as part of his or her professional practice.
C. Other Defenses and Insurance Issues
If a product liability action is brought against the professional using a 3D printer, there are also a number of arguments and defenses available beyond the simple argument that the claim should not sound in product liability’s strict liability regime. Even if trapped under product liability’s strict liability standard, it is important to recall that the plaintiff still has to show that the 3D printed product was in a “defective condition” and was “unreasonably dangerous.”17Restatement (Second) of Torts, § 402A(1) (1965).
After all, “[s]trict liability is not absolute liability and a manufacturer is not required to be the virtual insurer of its products.”18Fibreboard Corp. v. Fenton, 845 P.2d 1168, 1175 (Colo. 1993).
Further, the plaintiff has to show that the 3D printed product “is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.”19Restatement (Second) of Torts, § 402A(1)(b) (1965).
And, many defenses are available in product liability, such as state of the art, assumption of the risk, and comparative fault.
Another critical question for defending 3D printing product liability claims is whether there is available insurance for the person or entity who is engaging in 3D printing. If an engineer has professional liability insurance, but not completed operations / product liability insurance – there are questions on whether there is coverage for defense and especially indemnity of product liability claims under the policy. This, of course, will be based upon the claims asserted, the nature of the judgment, if any, and the details of the actual insurance policy. While the full scope of the insurance implications of 3D printing is beyond the scope of this article, practitioners should be mindful of the relatively novel insurance issues raised by 3D printing.
III. Product Liability Claims against the Manufacturers of the 3D Printer, the Software Developer, and the 3D Printer Materials
While a professional using a 3D printer may face potential liability for a defective product, the potential liability of the manufacturer of the 3D printing device itself, the 3D printer’s software developer, and the manufacturers of the raw materials used for 3D printing should be much more limited in most jurisdictions. This, of course, depends on the underlying products (i.e., the 3D printer itself, the software it uses, and the materials it uses) not being defective in and of themselves.
In most states, if a component part itself is not defective, the component part manufacturer will not be held liable if the final product in which the component part is placed is defective as a result of the use of the non-defective component part.20See e.g., Childress v. Gresen Mfg. Co., 888 F.2d 45, 48-49 (6th Cir. 1989); Bond v. E.I. Du Pont De Nemours & Co., 868 P.2d 1114, 1118-1119 (Colo. App. 1993).
Therefore, as long as the raw materials supplied by the material manufacturer are not defective, it appears unlikely that many courts would hold the raw material manufacturer liable for the defective ultimate product created with its materials. Nevertheless, as the raw material manufacturer may be the deep pocket, it certainly faces the risk of suit.
Similarly, as long as there was no defect in the 3D printer or the software, the manufacturer of the 3D printing device itself as well as the software developer should be relatively protected from liability for products defectively created by its devices/software. There have never been a significant number of claims against tooling device manufacturers for the products created by their tooling devices. And, such claims make little sense. The manufacturer of a screwdriver and hammer are not responsible for what dangerous products could be made by using the screwdriver and hammer. Nevertheless, if the 3D printing device or software has a defect itself, liability might attach to the manufacturer.21See Ferguson, 2016 U.S. Dist. LEXIS 54833, at *2 (alleging a 3D printer exploded).
To the extent these entities are the deep pockets, considering the novel issues in 3D printing, they may well still be litigation targets.
It is worth noting that contractual issues may also enter into any litigation naming both the professional using the 3D printer and the raw material manufacturer and/or the 3D printing company/software company. Each of these potential defendants have contractual relationships with each other. As such, their contracts may contain not only guidance for usage of the 3D printer, but also indemnification clauses.22An indemnification clause is a contractual method that “permits a party to protect itself [] by shifting liability for its faults to another.” Grubb & Ellis Mgmt. Servs., Inc. v. 407417 B.C., L.L.C., 213 Ariz. 83, 86, 138 P.3d 1210, 1213 (Ariz. Ct. App. 2006).
A close review of the indemnification clauses between the various potential defendants can be important to determine who ultimately bears financial responsibility for any judgment.
IV. Breach of Warranty Claims Against Professionals Using 3D Printing Devices
The potential for defective 3D printed products also raises the specter of Uniform Commercial Code breach of warranty claims against professionals. Article 2 of the Uniform Commercial Code addresses the sale of goods, and “goods” are defined as “all things (including specially manufactured goods) which are movable at the time of identification to the contract for sale.”23U.C.C. § 2-105(1).
A seller of a good can make express warranties or implied warranties on the condition and future performance of the goods.24U.C.C. §§ 2-313, 314, 315. The words “warrant” or “guarantee” are not required to form an express warranty. U.C.C. § 2-313(2). On the other hand, warranties can generally be limited or disclaimed. U.C.C. § 2-316.
One of the implied warranties is the implied warranty of merchantability if the good is sold by a merchant. A “merchant” is defined as “a person who deals in goods of the kind or otherwise by his occupation holds himself out as having knowledge or skill peculiar to the practices or goods involved in the transaction.”25U.C.C. § 2-104(1).
This definition likely includes any professional who prints a product using a 3D printer as part of his or her job.
Damages for breach of warranty can be significant. Per the Uniform Commercial Code, damages for breach of warranty are not just limited to the difference in the value of the goods between how they were if they were as warranted and how they actually were.26U.C.C. § 2-714.
Damages also include incidental damages and consequential damages.27U.C.C. § 2-715.
Consequential damages “include … injury to person or property proximately resulting from any breach of warranty.”28U.C.C. § 2-715(2)(b).
So, does a practicing dentist who has manufactured a crown now fall under Article 2 of the Uniform Commercial Code? Much like in the product liability arena where it is often difficult to distinguish whether a mixed seller/service relationship falls into the strict liability products liability category or the negligent service liability category, this determination under the Uniform Commercial Code is difficult. When the provision of goods and services are mixed, courts look to “whether their predominant factor … is the rendition of service, with goods incidentally involved (e.g., contract with artist for painting) or is a transaction of sale, with labor incidentally involved (e.g., insulation of a water heater in a bathroom).”29Bonebrake v. Cox, 499 F.2d 951, 960 (8th Cir. 1974).
As more 3D printing cases arise, it would not be surprising to see courts differ on their application of the Uniform Commercial Code to professionals in 3D printing cases.
V. Professional Negligence Claims against Professionals Using 3D Printing Devices
To return to the example that started this article, prior to the advent of readily available 3D printing, a crown for a tooth would be manufactured far from the dentist’s office by a third-party dental laboratory. If the crown was allegedly defective, that third-party would face product liability claims. To the extent that there were allegations that the dentist failed to meet his or her reasonable professional level of care, there would be dental malpractice claims brought against the dentist.
As discussed above, the blurring of the lines of manufacturer and product means that the dentist has the risk of facing product liability and similar claims. The same is true for all professionals printing products using 3D printing. But, the addition of these new claims does not remove the possibility of still facing professional liability claims.
As a general matter, a medical malpractice action is premised upon “the challenged conduct constitut[ing] medical treatment or bear[ing] a substantial relationship to the rendition of medical treatment.”3061 Am.Jur.2d, Physicians, Surgeons, and Other Healers § 285 (2019).
In the 3D crown printing example is the dentist involved in medical treatment by manufacturing the 3D crown? Certainly, the plaintiff’s counsel will make that argument. Additionally, as the service (i.e., the placement of the crown) is mixed with the product (i.e., the crown itself), typical professional negligence claims are likely to continue to be brought.
The standard that will be applied to a professional negligence claim is whether the care provided is consistent with what a similar trained health care provider would do under the same or similar circumstances.31See id.
That will necessarily result in an evaluation of the background, training, and experience of the provider in not only the care that was provided, but also the creation of the product that was provided to the patient. This type of claim will also require expert testimony to establish the standard of care for the services that are being provided. Some jurisdictions in fact require that a professional liability claim be certified by a competent expert before the plaintiff can even proceed with the claim.32E.g., Colo. Rev. Stat. § 13-20-602; Ga. Code Ann. § 9-11-9.1; Mich. Comp. Laws Serv. § 600.2912d.
In addition, there are many times specific requirements for an expert to be qualified and deemed competent to testify against a health care in a particular specialty. These are oftentimes difficult impediments to plaintiffs pursuing a professional liability claim that they will not encounter in a products liability action.
Another important consideration is that many states have caps on damages that limit the damages that can be awarded in professionally liability claims against health care providers. These laws may allow substantially less to be awarded for non-economic and economic damages in a medical malpractice claim than could be awarded for a products liability claim. That may be reason enough for a plaintiff to attempt characterize their claim as a products liability claim as opposed to one for professional liability.
3D manufacturing has unfortunately opened more possible theories of liability for plaintiffs and more risks for professionals who use this technology. This may well lead to a panoply of different claims being asserted based upon a single course of treatment.
VI. Conclusion
The increased use by professionals of 3D printing raises many interesting liability questions when there is an allegedly defective product manufactured. Defense counsel should explore, as appropriate in their jurisdiction, whether there are arguments that the allegedly defective product is not actually a product or good, and whether the professional is not actually a seller/merchant or a manufacturer of the product. There are many other liability implications of 3D printing, ranging from questions on insurance coverage to contractual indemnity provisions between the professional, the 3D printing company, and the underlying material suppliers. As 3D printing continues to grow, courts and practitioners will have to wrestle with these issues.
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