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PREP Act Immunity for COVID-19 Activities

04/06/2020

On March 17, 2020, Alex Azar, the Secretary of the Department of Health and Human Services (HHS) issued a declaration pursuant to the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. §247d-6d, relating to COVID-19. The Declaration certifies that the spread of COVID-19 constitutes a public health emergency. The March 17 Declaration was backdated to February 4, 2020 and will remain in place until October 1, 2024, unless shortened earlier.

The PREP Act can provide immunity to covered entities and individuals from liabilities stemming from the use of qualified products and processes, also known as countermeasures, to combat matters constituting a public health emergency. For the PREP Act to apply, the Secretary of HHS must issue a declaration after a determination that a disease constitutes a public health emergency.

As a result of the Declaration, Immunity under the PREP Act relating to COVID-19 precludes any and all claims under Federal or State law for a loss that is caused by, arises out of, or relates to, the administration to an individual or use of a covered countermeasure. Loss includes claims for death, physical, mental or emotional injury or disability, and any need for medical monitoring. A loss can also include property damages and business interruption losses. The immunity protection applies “without regard to the date of the occurrence, presentation or discovery of the loss.” There is a rebuttable presumption that the administration or use of a countermeasure was for a threat covered by the Declaration and a claimant will likely have to produce evidence to overcome the presumption.

There are limitations on the scope of immunity. The PREP Act does not provide immunity for willful misconduct. The Act defines willful misconduct as an act or omission that is undertaken intentionally to achieve a wrongful purpose or in disregard of a known or obvious risk that is so great to make it highly probably that harm will outweigh the benefit.

The grant of immunity can apply to manufacturers, distributors, program planners, and qualified persons and their officers, agents, and employees. The immunity also applies to the United States, its departments (such as the veterans administration), and Federal employees. Qualified persons include licensed health care professionals and other individuals authorized to prescribe, administer and dispense covered countermeasures under the law of the state in which the covered countermeasure was prescribed, administered, or dispensed.

Under the PREP Act and Declaration, covered countermeasures include antiviral and other drugs, diagnostics, devices, and vaccines used to treat, diagnose, cure, prevent, or mitigate COVID-19 or a virus mutating therefrom. The covered countermeasures can include qualified pandemic or epidemic products, security countermeasures, and drugs or devices for investigational or emergency use.

In its guidance, the Secretary has interpreted the act to preclude “liability claims alleging negligence by a manufacturer in creating a vaccine or negligence by a health care provider in prescribing the wrong dose, absent willful misconduct.” 85 Fed. Reg. at 15200. In addition, the liability protection may extend to slip and fall injuries or injuries from vehicle collisions involving a recipient receiving a countermeasure at a retail store serving as an administration or dispensing location. Id. The application of PREP Act immunity will be considered on a case by case basis and will likely be subject to future litigation and interpretation.

Following Secretary Azar’s issuance of the March 17 Declaration, Governor JB Pritzker issued an Executive Order (2020-19) providing for civil immunity for healthcare providers. Click here for more information on this order.

Heyl Royster’s attorneys remain available to help you respond to the COVID-19 public health emergency and its impacts on your operations.