COVID-19 Liability Immunity - What You Need to Know Now
Apr 06 2020
The COVID-19 Declaration was issued on March 10, 2020 under the authority of the Public Readiness and Emergency Preparedness Act of 2005 (“PREP Act”), codified at 42 U.S.C. §247d-6d, and is retroactively effective beginning February 4, 2020.
Manufacturers, distributors, program managers, “qualified persons” and their officials, agents, and employees authorized to prescribe, administer, deliver, distribute or dispense any antiviral, drug, biologic, or vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19, the transmission of SARS-CoV-2, or a virus mutating therefrom, or “any device used in the administration of any such product, and all components and constituent materials of any such product.”
Any person authorized to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures.
To permit the special use of drugs and other medical products during the COVID-19 pandemic that either have not yet been approved/cleared by the FDA or may be used off-label without the risk of liability in the event of a covered injury or loss. Under the PREP Act, if there are injuries as a result of Covered Countermeasures relating to a public health emergency, the relief available can be found via the Countermeasures Injury Compensation Program (“CICP”), which is charged with establishing a fund for such injuries.
Manufacturing, testing, development, distribution, administration, and use of the Covered Countermeasures.
Effective as of February 4, 2020 through October 2024, unless extended.
Anything used against the pandemic or against adverse events from these products, including antivirals, drugs, biologics, diagnostics, devices, and vaccines used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials.
Must be a qualified pandemic or epidemic product authorized for investigation or emergency use as defined in the PREP Act, the Food and Drug Cosmetic Act (“FDCA”), and the Public Health Service Act (“PHSA”).
This will likely depend on whether the product is authorized for use in connection with the COVID-19 pandemic.
The COVID-19 Declaration broadly defines those with “authority” in connection with the pandemic to include “the public agency or its delegate that has legal responsibility and authority for responding to an incident based on political or geographical (e.g., city, county, tribal, state or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority.”
Yes, as long as you meet the other requirements.
Yes, claims for “willful misconduct,” which require more than reckless or negligent behavior. To prove, the PREP Act requires clear and convincing evidence of an act or failure to act that is taken (1) intentionally to achieve a wrongful purpose; (2) knowingly without legal or factual justification; and (3) in disregard of a known of obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
No. However, immunity is not available for foreign claims.
The PREP Act, 42 U.S.C. § 247d-6d.
Yes, see, e.g., Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (3rd Dep’t 2012) (finding federal preemption over plaintiff’s state law claim based on the unconsented vaccination of a minor during the H1N1 epidemic).
Overall, the COVID-19 Declaration follows a similar framework as previous PREP Act declarations issued in response to Ebola, Zika, influenza, anthrax, botulinum, and smallpox over the past decade.
Womble Bond Dickinson (US) LLP’s Government Contracts practice has extensive experience guiding companies through the development and execution of over $2 billion in Biomedical Advanced Research and Development Authority (“BARDA”) contracts since the agency’s inception in 2006 in connection with the development of vaccines, therapeutics, and devices to combat anthrax, botulism, small pox, Ebola, burn injuries, and seasonal and pandemic flu.
1 Referred to herein as the “COVID-19 Declaration.” See 85 FR 15198 (available at https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures).