In the ultimate act of service learning, many universities and schools have shifted their focus during the COVID-19 crisis to manufacturing personal protective equipment (“PPE”) or providing PPE supplies to the local medical community and first responders. Colleges and schools across the country are using 3D printers to make masks, face shields, and ventilators. Many closed K-12 schools are also turning over their supplies of PPE to local hospitals and emergency responders. Although such altruism is admirable, it is important to be mindful of potential liabilities in taking on new manufacturing projects or donating school materials.
Schools that create or supply PPE have some level of protection from the March 2020 Declaration of the Secretary of Health and Human Services (“HHS”), which provides tort immunity under the Public Readiness and Emergency Preparedness Act (“PREP Act”) to entities involved in the creation or distribution of “countermeasures” to the COVID-19 virus. See 85 Fed. Reg. 15198. The types of covered “countermeasures” triggering PREP Act immunity include the manufacturing or supplying of any drug, medicine, vaccine, or device used to treat, diagnose, cure, mitigate, or prevent COVID-19, which could potentially include PPE.
Notably, the PREP Act covers not only products that treat or prevent COVID-19, but also products and technologies that merely “enhance” the effects of other products. This likely protects efforts similar to those underway at a private school in Columbus, Ohio, which has printed the headband portion of face shields, which are then added to other components made by larger manufacturers in the Columbus area. PREP Act protection also likely extends to the dozens of colleges and universities across the country working on the development and testing of potential vaccines for COVID-19.
The scope of immunity under the PREP Act, however, is not unlimited. Schools should discuss with counsel whether the immunity provided under the PREP Act applies to the products that they plan to produce. If a school is not adequately covered, it could face substantial exposure to regulatory action or product liability claims.
Schools should be especially wary of statements and claims made to the public about their product’s ability to treat or protect against COVID-19, particularly where those statements may lack medical or scientific support. Inadequate or misleading instructions about the functionality or intended use of a mask, face shield, ventilator, or vaccine could expose schools to regulatory enforcement actions, or private actions for negligence or other product liability claims, as well as commercial claims for breach of warranty. Schools should thus consider placing appropriate disclaimers or warning labels on their products, informing the end user that the product may not prevent the transmission of COVID-19 or fully treat the virus. Schools are advised to consult with counsel in crafting appropriate language.
Public schools, moreover, must be aware of applicable federal, state, and local restrictions, which could affect their capacity to donate PPE. The State of Ohio, for example, restricts the circumstances under which public school districts may make donations. Sending district-owned PPE to the local fire or police department may violate state law or make the district susceptible to an audit. Any educational entities planning to donate (or even, depending on state law, planning to sell PPE), should be mindful of restrictions on their capacity to engage in such transactions.
COVID-19 will not prevent future compliance audits, government inquiries, and other post hoc investigations into a school’s “Good Samaritan” efforts. Accordingly, while there are many ways schools and universities can help out during this pandemic—including the production or donation of PPE—they must approach such activities carefully, keeping in mind that many of the regulations they face during normal times still apply.