Recently, my colleagues Colin Kelly, Caroline Gieser, Michael Polatsek, and I thought about the role that additive manufacturing (3D-printing) is playing in today’s brave new world. As COVID-19 continues to cause critical manufacturing shortages while also increasing demand for emergency medical and protective equipment, the government and private industry are coming together with the help of 3D-printing technology to tackle both problems simultaneously. Manufacturers large and small are arming themselves with 3D-printing to produce much-needed medical and protective products that are in high demand but short supply. The list of critical COVID-19-related products being manufactured through 3D-printing include nasal swabs, ventilators, face shields, gowns, masks and even respirators. Yet additive manufacturing is still a relatively new process and certain technical and practical limitations remain. Indeed, as the U.S. Food and Drug Administration (FDA) noted in a March 26, 2020, communication, “3D-printed PPE are unlikely to provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.”
Up until very recently, discussions about the risks associated with 3D-printing have been mostly hypotheticals reserved for academics and product liability lawyers, but COVID-19 has now raised the question: Will well-intentioned additive manufacturers (large and small) face personal injury claims for helping address COVID-19-related spikes in demand for medical and protective equipment?
Unless they qualify for some type of immunity under the Defense Production Act (DPA) or the Public Readiness and Emergency Preparedness Act (PREP Act), the answer is likely yes in those states that have expansive definitions of what constitutes a “seller” under strict liability laws. Further, state Good Samaritan statutes provide very limited to no immunity for private manufacturers.
The Defense Production Act
Although government may encourage and in some instances compel private industry to manufacture certain products, those manufacturers are by no means automatically shielded from subsequent tort claims.
For example, on March 27, 2020, President Trump invoked the DPA and required General Motors to produce ventilators. Under the DPA, the president can direct private companies to accept and prioritize manufacturing contracts in order to bolster national defense. Private companies that are tasked with accepting such contracts, however, are not automatically afforded blanket tort immunity under the DPA for liability to injured third parties. At best, such companies may only benefit from some immunity from breach-of-contract suits. See Hercules Inc. v. U.S., 516 U.S. 417 (1996); U.S. v. Gen. Dynamics Corp., CA No. 4-87-312-K, 1988 U.S. Dist. LEXIS 17256, at *12-13 (N.D. Tex. June 9, 1988) (“. . . the DPA was intended to cover claims based on contracts with third-parties that a given defense contractor had to breach in order to fulfill its respective federal defense contract.”); In re Agent Orange Prod. Liability Litig., 597 F. Supp. 740, 845 (E.D.N.Y. 1984) (explaining, in dicta, that “[i]f [the Act] is to be applied to tort claims at all, it should only be read to bar claims for strict liability, not negligence.”). Nor are private companies automatically granted indemnity for tort claims arising from harm to third parties. See Hercules Inc., 516 U.S. at 430 n.14. Only in some limited circumstances can private manufacturers raise a government contractor defense to claims related to performance under a DPA contract. See generally Campbell-Ewald Co. v. Gomez, 136 S. Ct. 663 (2016) (discussing government contractor immunity generally).
In order to mitigate future tort liability, companies both large and small should at the very least strictly adhere to FDA’s previously issued guidance on the Technical Considerations for Additive Manufactured Medical Devices. That guidance outlines the agency’s recommendations for 3D-printed devices from the device stage to process validation and acceptance activities of finished devices. Companies should also maintain open lines of communication with FDA regarding any questions that they may have through the agency’s recently established e-mail address specifically geared to COVID-19 manufacturing-related issues: COVIDManufacturing@fda.hhs.gov.
The Public Readiness and Emergency Preparedness Act
Companies that produce medical and protective products pursuant to an FDA Emergency Use Authorization (EUA) may benefit from some level of tort immunity under the PREP Act, which was enacted in 2005 and amended the Public Health Service Act (PHS Act). The amendments “added new legal authorities to the [PHS Act] to provide liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures against . . . epidemics and pandemics.” The amendments also authorized the Secretary of Health and Human Services to issue a declaration “that provides immunity from liability for any loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases . . . determined in the Declaration to constitute a present or credible risk of a future public health emergency.”
On February 4, 2020, the Secretary announced that, pursuant to section 564 of the Federal Food, Drug and Cosmetic Act (FD&C Act), a public health emergency existed regarding COVID-19 and authorized the emergency use of in vitro diagnostics for detection or diagnoses of the novel coronavirus. The Secretary followed by officially stating on March 24, 2020, that circumstances existed to justify the authorization of emergency use of medical devices, which included “alternative products used as medical devices.” Since then, FDA has issued numerous EUA Letters for medical devices authorizing the manufacture and distribution of products including ventilators, personal protective equipment and laboratory tests. At least one company has already reportedly received authorization from FDA to produce a 3D-printed valve that allows a single ventilator to treat up to four patients.
Such EUAs sometimes dispense with certain FDA requirements for authorized products that would normally apply to the production of medical devices. For instance, FDA’s March 24, 2020, ventilators EUA letter waives certain current good manufacturing practice requirements under 21 CFR Part 820, as well as “registration and listing requirements, including the requirements under 21 CFR Part 807.”
On March 10, 2020, pursuant to the authority granted by the PREP Act, the Secretary issued a “Notice of Declaration under the [PREP Act] for medical countermeasures against COVID-19.” In the Declaration, the Secretary recommended the manufacture of Covered Countermeasures, which are defined in part to include devices and vaccines used to treat or mitigate COVID-19, or “any device used in the administration of any such product, and all components and constitute materials of any such product.” The Declaration further states, in part, that liability immunity is afforded to certain “Covered Persons,” which include persons who are “authorized to perform an activity under an [EUA] in accordance with Section 564 of the FD&C Act.”
Though there does not appear to be a great deal of primary authority interpreting the viability of tort claims in light of the PREP Act, at least one court has recognized that the manufacturer of a vaccine to treat H1N1 influenza pursuant to the directive of and under contract with the federal government was immune from suit under both Federal and State law pursuant to the PREP Act. See Kehler v. Hood, No. 4:11CV1416, 2012 WL 1945952, at *2–3 (E.D. Mo. May 30, 2012) (holding manufacturer was absolutely immune from liability for any type of loss caused by the vaccine pursuant to the PREP Act, where the Secretary had previously “identified the H1N1 virus as a public health emergency and made the 2009 vaccine a covered countermeasure under the PREP Act”). The court further recognized that the only exception to the immunity afforded by the PREP Act is for “death or serious injury proximately caused by willful misconduct.” Id. at *2 (quoting 42 U.S.C. § 247d–6d(a)(1)). For further discussion of liability immunity under the PREP Act, please see the March 19, 2020, installment of Shook’s COVID-19 primer series, “New Federal Law Extends Existing Tort Protections for Makers of Certain Products Used to Combat COVID-19.”
Common Law Defenses for 3D Manufacturers
Despite uncertainty about potential tort liability shields under the DPA and the PREP Act, one Fortune 100 technology company has already delivered 1,000 3D-printed parts to local hospitals close to the company’s various R&D centers across the United States and Europe. Similarly, multiple companies have released their 3D-printing designs and programs for free and widespread download anywhere in the world. Likewise, colleges across the United States are deploying their 3D-printing labs to manufacture respirators and protective equipment.
Occasional/Casual Sellers Defense
For most of these temporary respirator and personal protection manufacturers, if emergency use authorizations do not provide complete immunity, at least two common law defenses could potentially help shield these companies from strict tort liability in some states. First, for any manufacturer that is not in the medical supply or manufacturing industry, that manufacturer might argue that it does not meet the definition of a product “seller.” Comment f to the Restatement of Torts 402 A provides:
The basis for strict liability is “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 . . . . This basis is lacking in the case of the ordinary individual who makes the isolated sale, and he is not liable . . . in the absence of his negligence.”
This would not provide help in cases of ordinary negligence but would provide some defense against a strict liability defect claim. For states that follow the Third Restatement of Torts, § 1, manufacturers would want to argue that their emergency 3D assistance is purely casual, occasional or otherwise very limited. Moreover, in states that follow the Third Restatement of Torts, strict liability “applies only to manufacturers and other commercial sellers and distributors who are engaged in the business of selling or otherwise distributing the type of product that harmed the plaintiff.” Restatement (Third) of Torts: Prod. Liab. § 1. Under comment C, “[i]t is not necessary that a commercial seller or distributor be engaged exclusively or even primarily in selling or otherwise distributing the type of product that injured the plaintiff, so long as the sale of the product is other than occasional or casual.” There is no clear delineation on the number of 3D-manufactured products that will render a casual manufacturer a “seller” for purposes of strict liability, but certainly, the larger and longer the production, the greater the risk of being deemed a “seller” for purposes of strict liability.
State Good Samaritan Protections
Although all 50 states and the District of Columbia have adopted some form of Good Samaritan principles in place for individuals who render emergency aid, most have not expressly expanded the definition of individuals to include companies. For many large population states such as California, Good Samaritan laws have strictly been applied to individual people. In states that apply Good Samaritan laws to corporations, such as Georgia and Delaware, the corporation generally must be acting without the expectation of being paid or at the direction of the state or federal government.
Clearly, an individual who voluntarily provides 3D-printed personal protective equipment or medical equipment could fall under Good Samaritan liability shields, but when a corporation does the same, the law is much less forgiving.
Accordingly, a manufacturer wishing to assist in the COVID-19 crisis will have the most tort protection if acting under the DPA, the PREP Act, or at the direction of a state or the federal government.