The COVID-19 pandemic has brought a number of legal questions along with its millions of infections. What options are there for those who are seeking a civil case related to COVID-19? On March 10, 2020, the federal government made a Declaration Under the PREP Act for Medical Countermeasures Against COVID-19, limiting what cases may be brought and whom they may be brought against.
Whom does the Declaration protect?
The Declaration provides liability immunity for certain individuals for activities related to medical countermeasures against COVID-19. This immunity protects Covered Persons, as defined by the Declaration, for Covered Countermeasures, outlined by the Declaration. “Covered Persons” include manufacturers, distributors, program planners, and qualified persons, including their officials, agents, and employees, and the United States. “Qualified persons” means licensed health professionals or other individuals authorized to prescribe, administer, or dispense Covered Countermeasures.
What are considered ‘Covered Countermeasures’?
Covered Countermeasures are any:
antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, 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 of any such product.
In an advisory opinion, the Department of Health & Human Services provided guidance on how to determine whether something qualifies as a countermeasure. First, the product must be used for COVID-19. Second, it must either be approved, licensed or cleared by the FDA; authorized under an emergency use authorization; described in an emergency use instruction; or used under either an investigational new drug application or an investigational device exemption. The list of Covered Countermeasures is expansive.
My case involves a Covered Countermeasure and Covered Person. What relief may I seek?
Despite the broad coverage the PREP Act provides to health providers relating to COVID-19, there is an opportunity for relief, alternative to litigation. The Countermeasures Injury Compensation Program (CICP) provides an opportunity for those who have been seriously injured or died as a result of a countermeasure to seek compensation.
Under the CICP, an individual or representative may file a claim for compensation within one year of the implementation of the countermeasure. CICP will compensate for reasonable medical benefits, lost wages, and death benefits for compensable claims. CICP only compensates for claims resulting in serious injury or death and will not compensate claims for emotional injury, fear of injury, business losses, or other claims.
While the PREP Act provides immunity to a number of individuals for acts relating to the COVID-19 pandemic, cases where an individual is seriously injured or dies are not without any recompense. The CICP as of December 1, 2021, has seen 5,630 alleged COVID-19 Countermeasure Claims filed.