The PREP Act and Liability for EUA Medical Equipment


During the COVID-19 Pandemic, in order to address shortages of crucial medical equipment such as face masks and ventilators, the Food and Drug Administration (FDA) issued emergency use authorizations (EUAs) to allow certain manufacturers to make medical equipment who do not normally do so. Any manufacturer who produced this medical equipment under an EUA was given immunity from product liability under the Public Readiness and Emergency Preparedness (PREP) Act. However, the immunity given under the PREP Act is neither absolute nor permanent, and manufacturers should know what to expect when its protections expire.

               The PREP Act gives the Secretary of the Department of Health and Human Services (HHS) the authority to declare a public health emergency, which grants immunity from lawsuits to manufacturers who produce medical equipment to address this emergency. This particularly includes manufacturers who switch from producing other things, such as car parts or air conditioners, to producing medical equipment for the sake of fulfilling the immediate public need. This is to ensure manufacturers who produce desperately needed medical equipment do not face financial or legal difficulties during a public health emergency.

               There are two caveats to the legal immunity conferred by the PREP Act, however. First, it does not grant immunity for willful misconduct, meaning that intentional harm can still result in legal liability for EUA medical manufacturers. Second, the immunity conferred by the PREP Act only lasts for a limited time after the public health emergency has been declared. In the case of the COVID-19 crisis, the immunity for medical equipment manufactured during this time will lapse on October 1, 2024, after which point the manufacturer will be liable for harm caused by those products.

               This is important to consider for any manufacturer producing medical equipment under an EUA, because typically, medical equipment falls under strict liability for manufacturing defects. In other words, without the immunity conferred by the PREP Act, any kind of defect in the product that results in harm to a patient can result in legal liability. Thus, manufacturers should prepare for the possibility that they could be held liable for harm caused by products they manufacture now, if that equipment is still in use once PREP Act protections expire.

               If you are injured as the result of defective medical equipment, you should put the experienced personal injury attorneys of Georgaklis & Mallas, PLLC on your side. They will vigorously represent you and fight for the compensation you and your family deserve. The attorneys at Georgaklis & Mallas, PLLC can handle cases throughout the five boroughs and beyond including in Brooklyn, Staten Island, Long Island, New Jersey, Manhattan, Queens, the Bronx, and upstate New York. For more information or to schedule a consultation, please call (718) 238-2400.