With so much still unknown about the vaccine and how to manage its use at my location(s), what is a good first step from a risk management standpoint?
The best first step in this process is to establish protocols, rules, guidance, and best practices that comply with the guidance and regulations of both the federal and local health authorities. This should be done via a coordinated effort of the executive management team, Human Resources and the assistance of outside counsel. This is your first line of “defense” for addressing the myriad of issues and questions that may arise from the vaccine “rollout” across the U.S.
Does the PREP Act offer my organization immunity protections that are broader than my local liability rules and regulations?
The PREP Act guarantees of immunity are available to those who manufacture, distribute, administer, use, and coordinate drugs and devices used to combat COVID-19. This is generally good news for most senior care organizations under the current guidelines for the application of this federal law.
The purpose of the Act is to encourage the quick and efficient development and deployment of countermeasures—like equipment, diagnostics, treatments, and vaccines—during a public health crisis, like the current COVID-19 pandemic. In January 2020, HHS Secretary Azar declared a public health emergency on January 31, 2020. He then issued a Declaration (see 85 F.R. 15198), effective February 4, 2020, making PREP Act protections available in the fight against COVID-19.
What are the limitations on immunity under the PREP Act?
The scope of immunity is broad, but not absolute. Liability protections are not available in situations involving willful misconduct that proximately caused death or serious injury. The “willful misconduct” exception is a high bar: lawsuits must go before a three-judge court in the U.S. District Court for the District of Columbia and a plaintiff must establish that the willful misconduct proximately caused death or serious injury.
To date, the PREP Act immunities have not been found to preempt the state law causes of action upon which most claims are filed. The Secretary of the Department of Health and Human Services has issued very pointed advisory opinions and comments that the PREP Act should completely preempt any and all state law causes of action, thus rendering a uniform and consistent legal platform nationwide.