The Secretary of the Department of Health and Human Services issued a declaration1 providing liability immunity to certain individuals and entities against covered claims of loss relating to the manufacture, distribution, administration, or use of medical countermeasures (“Covered Countermeasures”), except for claims involving “willful misconduct.”
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.
Who is this primarily relevant to?
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.”
Who is a “qualified person”?
Any person authorized to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures.
What is the purpose of the COVID-19 Declaration?
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.
What activities are covered?
Manufacturing, testing, development, distribution, administration, and use of the Covered Countermeasures.
When did it go into effect and how long does it last?
Effective as of February 4, 2020 through October 2024, unless extended.
What are Covered Countermeasures?
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”).
What are the key limitations/qualifications on immunity protection?
- Some form of premarket approval is required. The Covered Countermeasure must be approved or cleared by the FDA under the FDCA; licensed under the PHSA; or authorized for emergency use by the FDA under applicable provisions of the FDCA.
- Must be qualified pandemic or epidemic products, security countermeasures, or drugs, biologics, or devices authorized for emergency or investigational use.
- Only for “recommended activities” involving Covered Countermeasures related to present or future federal contracts or other federal transactions or agreements, or activities authorized by authorities with jurisdiction to prescribe, administer, deliver, distribute, or dispense Covered Countermeasures following an emergency declaration.
- Does not apply to death or serious physical injury caused by willful misconduct.
- Not available for foreign claims.
- Claim must arise from conduct that is directly related to the development/distribution of a Covered Countermeasure.
Does my product qualify for immunity protection?
This will likely depend on whether the product is authorized for use in connection with the COVID-19 pandemic.
Who has “authority” in connection with the 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.”
Could this provide liability immunity for my clinical trial?
Yes, as long as you meet the other requirements.
Are there any claims not covered by the COVID-19 Declaration?
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.
Is there a geographic limitation?
No. However, immunity is not available for foreign claims.
What is the authority for the COVID-19 Declaration?
The PREP Act, 42 U.S.C. § 247d-6d.
Is there precedent supporting this immunity?
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).
How does the COVID-19 Declaration compare to prior declarations?
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.
For additional information on the practical application and effect of the liability immunity available thereunder, please contact Sara Tucker, Kelley Doran, or Suzanne Boehm. Sara has specific experience counseling Fortune 500 companies related to product liability risk mitigation, particularly in highly regulated industries such as pharmaceutical and medical devices. Kelley, Suzanne and Womble Bond Dickinson (US) LLP’s Government Contracts practice have 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).