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March 31, 2016

Law and Regulation of 3-D Printed Medical Devices

As printed in Law360, New York

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3-D or additive printing is the process of making a three-dimensional, solid object from a digital model by layering material until the printed object is formed into its intended shape or design. Though the technology has been around for decades, the latest applications of this technology in the health care industry are getting a lot of buzz and raising a whole host of questions.

The use of 3-D printing to create custom medical devices and pharmaceuticals is here and already well underway. Additive printing provides our scientific and medical communities with an undeniable opportunity for significant advancements in delivering health care around the globe. Indeed, the potential of utilizing this technology to design, manufacture and deliver drugs and devices is one of the most significant advancements in health care. Pharmaceuticals can now be printed into custom shapes to speed up or control absorption rates. Highly customized surgical implants are delivering in their promise to reduce surgery times, provide less invasive procedures, and result in faster recovery times for the patient. 3-D printing has the potential to revolutionize the way medicine is practiced in the 21st century.

But just as 3-D printing is providing the drug and medical device industry with opportunities to rethink design, manufacture and delivery of their products, governmental agencies and courts alike are beginning to grapple with novel issues of regulation and questions of product liability. The following is a brief overview of how the U.S. Food and Drug Administration and courts are working through the regulatory and legal implications of this technology in medicine.

3-D Printed Drugs and Medical Devices on the Market Today

The FDA broke new ground in August 2015 when it approved Spritam, Aprecia Pharmaceuticals Co.’s 3-D printed seizure drug. Spritam is made with a proprietary technology, using 3-D printing to produce a porous formulation of a pill that rapidly disintegrates with a sip of liquid. It is the only 3-D printed drug approved by the FDA. Via the 510(k) process, the FDA has also cleared medical devices such as hearing aids, dental crowns, bone tether plates, skull plates, hip cups, spinal cages, knee trays, facial implants, screws, surgical instruments and Invisalign braces. More than 85 3-D printed medical devices have been cleared for use through the 510(k) premarket notification process, but so far none have gone through the more arduous premarket approval (PMA) process.

Do 3-D Printed Items Fall Within the FDA’s Custom Device Exemption?

The real beauty of 3-D printing technology is its ability to produce one-of-a kind items very easily and efficiently. Until now, the manufacturing of medical devices has required machined parts or special molds that made custom fabrication economically infeasible. But, 3-D printing raises unique regulatory questions.

3-D printed items may not be classified as medical devices at all (e.g., certain component parts) or they may be classified as Class I devices (e.g., certain types of medical prostheses). For those types of devices, the rigors of FDA approval, clearance or exemption may be unnecessary. However, for other 3-D printed devices, companies will need to seek 510(k) clearance, premarket approval, a humanitarian device exemption (HDE) or a custom device exemption (CDE).

In 2014, the FDA revamped the requirements that devices must meet to qualify for a CDE. The definition in the Code of Federal Regulations did not change, but the FDA’s “current thinking,” in the form of guidance, added annual reporting requirements and the possibility for multiple units of a device type (five units or fewer per year) to qualify for the exemption. A 3-D printed device utilizing a CDE must meet the following criteria:

1) be created to comply with the order of an individual physician/health care professional;

2) “necessarily deviate” from generally available devices;

3) not be generally available; AND

4) treat a unique condition that no other device is domestically available to treat.

Additionally, the device must also:

5) be intended to meet the special needs of a physician or be intended for an individual patient;

6) be assembled or finished to accommodate unique needs of individuals;

7) treat a sufficiently rare condition such that clinical trials would not be feasible; AND

8) be produced in quantities of five or fewer items or sets per year.

Assuming all these criteria are met, just what does the exemption really buy the creator of the custom device? A 510(k) or other marketing application is not needed with a CDE. But, instead of preparing a submission for a one-time clearance, a detailed report is now required every year. As for labeling requirements, custom devices have their own set of requirements, not dissimilar from the labeling elements of a regular device. One benefit of a CDE is that an investigational device exemption (IDE) is not needed for a custom device used in a clinical trial setting.

The annual report that must be submitted by the manufacturer of a custom device is not trivial. The number of patients and number of custom devices used in a patient should be accounted for. A truthful and accurate statement must be signed. An explanation of why the device “necessarily deviates” from traditional premarket requirements is needed — with references. If a custom device is physician-centric (intended for physician use and not for a specific patient), additional details are needed. On the other hand, annual reporting obligations exist with respect to PMA and HDE devices as well.

The FDA’s narrow custom device exemption may be available to some 3-D printed products. However, regulatory compliance must be considered for 3-D printed medical devices whether or not they meet the requirements of the custom device exemption. Companies responsible for products classified as medical devices will need at a minimum to register their establishment and list their devices and comply with other general controls. Additional issues to consider include classification, potential requirements for premarket application and quality system requirements, including design controls and supplier controls.

3-D printed devices that do not fit the very narrow criteria for the custom device exemption might fit into the HDE or compassionate use protocol for devices under investigation. Compassionate use applies where an investigational device provides the only option available for a patient faced with a serious condition. Compassionate use requires prior FDA approval, like many other device trials.

3-D printed devices may also qualify for an HDE application. An HDE application is similar to a PMA, but because a humanitarian use device (HUD) is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. However, the HDE must contain sufficient information for the FDA to determine that the probable benefit to health outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. An approved HDE authorizes marketing of an HUD.

What Quality System Issues Need to be Considered?

If 3-D printed devices do not fit the custom device exemption, then they have the same quality system requirements as conventional devices. Class II, III and some Class I devices are subject to design controls. Design controls should be addressed as soon as the device project transitions from “research” and goes into “development.” What testing is necessary to verify the design? How will the design outputs be validated?

Manufacturing of 3-D devices under the quality system regulation presents its own unique challenges. Process validation differs. How is acceptance criteria determined? While the quality system regulation is very flexible, it was not really written with 3-D printing in mind, and compliance requires thinking that is just as creative as the process.

Manufacturers of Class II, III and some Class I devices will also need to consider their vendor and supplier qualification programs and make sure adequate controls are in place for the management of any outsourced goods or services.

The FDA and Product Liability

Of course, how the FDA treats a drug or medical device has implications for product liability lawsuits, since FDA approval of some medical devices can preempt state law tort claims.[1] Whether drugs or devices are cleared under 510(k), approved by the more rigorous premarket approval process or exempted entirely, impacts what types of preemption defenses might be available against design or  warnings claims. But, how the FDA will treat 3-D printed products is only the first question that 3-D printing poses for product liability law.

Should Strict Liability Apply?

3-D printing does raise a kind of philosophical question for strict liability. The typical justifications for imposing strict liability have been: (1) product manufacturers and sellers are better able to absorb and distribute the losses associated with the social costs of accidents arising from product defects; (2) enterprises are better able to respond to safety incentives posed by liability rules; and (3) it is reasonable that those who profit from introducing risk to society should bear the costs of accidents caused by defects in their products.[2] But 3-D printing is a fundamentally democratizing technology that allows a whole host of new entities (including doctors, hospitals and patients themselves) to create products. Given this shift, should or can strict liability even apply?

How Would Strict Liability Apply?

For typical medical products, any party within the product’s chain of distribution can be strictly liable: (1) the product’s manufacturer; (2) the manufacturer of a component part; (3) the party who assembles or installs/implants the product; and (4) the intermediary who sells the product. 3-D printers themselves fit fairly well within the standard paradigm for strict liability, as do potentially defective 3-D printed products that come from an outside company that regularly manufactures and sells 3-D printed products. In contrast, the 3-D printing process — where a noncommercial manufacturer or seller can create or distribute a product that began with a software file — challenges the traditional understanding of manufacturer, seller and even product.

Strict liability began as the creation of the California Supreme Court, which first held that manufacturers could be liable without fault for injuries caused by a defective product.[3] Strict liability was included in the Restatement (Second) of Torts and widely adopted thereafter. For strict liability, it is critical to identify the commercial manufacturer or seller as well as the product — so critical, in fact, that some have posited that there could be instances in which no one will be strictly liable for an injury caused by a 3-D printed product.[4] But this projection assumes product liability law will remain static — an assumption that is at odds with the evolution of the law in this area over the past decades. At this stage, the compatibility of 3-D printing and product liability law might be better viewed as a series of questions than answers.

Who is a Commercial Seller?

Assuming harm does not stem from a defective printer, the first question for strict liability concerns who could be liable as a seller. As noted, strict liability generally applies only to commercial sellers and not occasional ones. Doctors and hospitals typically do not qualify as commercial sellers.[5] And tracing the chain of distribution back to the software may not help either. Independent designers of products are generally not held strictly liable for defects in their designs.[6]

Yet hospitals or providers who print their own drugs or devices may see their status shift if they begin doing so in higher volume, or providing the products to more than just their own patients. And it is plausible that courts could begin to change their view on designers, who are presently unlikely to be deemed a product manufacturer or seller. Given the nature of 3-D printed products — where the actual creation of the physical product is done by a machine with limited if any human contribution, and potentially by a doctor or even patient who presses a button — the line between designing and manufacturing becomes increasingly blurred. This lack of distinction could drive other changes.

What is the Product?

A 3-D printed drug or device begins with a computer file. So could that be the product? Not so far. Courts in other contexts have held that software is not a product.[7] And electronic code also does not constitute a product under the Restatement (Third) of Torts, which defines a product as “tangible personal property distributed commercially for use or consumption.”[8]

But the law is still unsettled. In a somewhat analogous situation, the Ninth Circuit held in Winter v. G.P. Putnam’s Sons that information in a book is not a product for the purposes of product liability.[9] Yet the dictum in the same case suggested software could be.[10] And courts have found that some intangible items, like electricity, can be products for the purpose of strict liability.[11] Aeronautical maps and charts have also qualified as products for strict liability.[12]

Has the Product Undergone a Substantial Change?

The Second Restatement requires that the product reach the consumer without substantial change. Applying that rule to 3-D printed products raises still more questions.[13] On the one hand, software, itself, cannot cause harm — only the tangible result in the form of a drug or device can do that. Courts may, as they have for architectural plans, view the transformation of a digital design to a tangible drug or device as a substantial change that prevents the plaintiff from prevailing in strict liability.[14]

But on the other hand, the concept of substantial change may be ill-suited to the 3-D printing process. Printing the actual tangible item does not necessarily “change” the software; it fulfills its purpose. Courts could conclude that the printed item and the software from which it was derived cannot be separated and both constitute the “product.”

What About Negligence?

The challenges in applying strict liability to 3-D printed products may relegate plaintiffs to claims in negligence. For negligence there is no need to identify a commercial seller or a product — the focus is instead on the duty of the defendant to the injured party. Negligence is a viable alternative, but also has its hurdles for would-be plaintiffs. Establishing the standard of care for new types of defendants or theories of negligence in this context, and finding experts to support that standard, could have its own challenges. For example, doctors and hospitals — who have little-to-no prior experience in manufacturing — are unlikely to have a sophisticated understanding of the capabilities of 3-D printers and best practices for using them. Given potential knowledge gaps in the unorthodox supply chain for 3-D printed products, could there begin to be widespread recognition of a duty to train doctors and hospital staff on proper use of 3-D printers?

3-D Printing and Other Tort Doctrines

As courts begin to address the concepts of product and manufacturer in the context of 3-D printed drugs and medical device, other tenets of product liability law may offer guidance to defendants. For example, there is no logical reason why the learned intermediary doctrine would not apply to these products. And indeed, the first federal court to examine the issue, in Buckley v. Align Technologies Inc., held that the manufacturer of custom orthodontic aligners had no duty to warn the patient that the aligners would not treat malocclusions.[15] The court concluded that the learned intermediary rule barred the plaintiff’s claims against Align because she had not alleged that Align somehow misled the plaintiff’s dentist.[16] And defendants involved in the chain of distribution for a 3-D printed drug or device that copies a non-3-D-printed drug or device might also argue they are analogous to manufacturers of generic drugs, which enjoy preemption protections. The software designer, or even the manufacturer of a 3-D printer itself, might also argue that they are akin to component parts suppliers, which in many states are not liable in strict liability for finished products that incorporate their components.

The legal questions posed by 3-D printing are fascinating but remain largely unanswered. But, the rapidly expanding use of these devices will soon require regulators and courts to wade into this uncharted territory and map out solutions.

—By Lindsey Adams-Hess and Kim Schmid of Bowman and Brooke LLP and Amy Fowler of DuVal & Associates PA

Lindsey Adams-Hess is an associate in Bowman and Brooke's San Jose, California, office. Kim Schmid is an executive managing partner in Bowman and Brooke's Minneapolis office where she leads the firm’s Life Sciences practice group.

Amy Fowler is an associate in DuVal & Associates' Minneapolis office.

The opinions expressed are those of the author(s) and do not necessarily reflect the views of the firm, its clients, or Portfolio Media Inc., or any of its or their respective affiliates. This article is for general information purposes and is not intended to be and should not be taken as legal advice.

[1] See, e.g., Riegel v. Medtronic, Inc., 522 U.S. 312 (2008).

[2] See Nora Freeman Engstrom, 3-D Printing and Product Liability: Identifying the Obstacles, 162 U. Pa. L. Rev. Online 35, 41 (2013); Greenman v. Yuba Power Prods., Inc., 59 Cal 2d 57 (1963).

[3] Greenman, 59 Cal 2d 57.

[4] Engstrom, supra note ii, at 37.

[5] See, e.g., Restatement (Third) of Torts, Products Liability, § 20 (2015) (“[I]n a strong majority of jurisdictions, hospitals are not to be sellers of products they supply in conjunction with the provision of medical care, regardless of the circumstances.”); see also Cafazzo v. Cent. Med. Health Serv.’s, Inc., 668 A.2d 521, 532 (1995).

[6] Melissa Evans Buss, Products Liability and Intellectual Property Licensors, 27 Wm. Mitchell L. Rev. 229, 313-14 (2000)

[7] See, e.g., U.S. v. Aleynikov, 676 F.3-D 71, 73 (2d Cir. 2012); see also ClearCorrectOperating, LLC v. Int’l Trade Comm’n, No. 2014-1527, 2015 WL 6875205 (Fed. Cir. Nov. 10, 2015).

[8] Restatement (Third) of Torts: Prods. Liab. § 19 (2015) (emphasis added).

[9] Winter v. G.P. Putnam’s Sons, 938 F. 2d 1033, 1039 (9th Cir. 1991).

[10]Id. at 1036.

[11] See, e.g., Schriner v. Pa. Power & Light Co., 501 A.2d 1128, 1133 (1985); Stein v. S. Cal. Edison Co., 7 Cal. App.4th 565, 571 (1992).

[12] See Brockesby v. U.S., 767 F.2d 1288, 1295 (9th Cir. 1985) (aeronautical chart); Saloomey v. Jeppesen & Co., 707 F.2d 671, 676-77 (2d. Cir. 1983) (navigational charts).

[13] See Restatement (Second) of Torts § 402A(1)(b) & cmt. P.

[14] See, e.g., K-Mart Corp. v. Midcon Realty Grp. Of Conn. Ltd., 489 F. Supp. 813 (D. Conn. 1980).

[15] Buckley v. Align Tech., Inc., No. 5:13-CV-02812-EJD, 2015 WL 5698751 (N.D. Cal. Sept. 29, 2015).

[16] Id.