During the COVID-19 crisis, a number of state governments, including Kentucky’s, have taken steps to adopt new protections for the front-line healthcare providers who are responding to patient care needs under unprecedented circumstances. These state laws supplement federal protections that apply in limited circumstances. The laws clarify that COVID-19 triggers pre-existing protections in health emergency situations and identify additional actions that are under the umbrella of immunity.
Immunity is a defense in civil lawsuits, like medical negligence cases. Historically, immunity is put in place when there has been a policy determination that certain actions are beneficial to society and should not be deterred by the threat of litigation. Immunity as a legal concept does not mean that a claim or a lawsuit can never be filed. Rather, it is a defense that is available in a legal action. A rare type of immunity – absolute immunity – can be established at the outset of a case. The types of immunity discussed in this article, though, are not absolute. If a suit is filed and one of these defenses may be available, the parties will often have to take some proof to establish that the circumstances required for immunity to apply are present and the immunity defense applies.
Kentucky, like many other states, has certain “Good Samaritan” rules pre-dating COVID-19 that can apply to healthcare providers. For example, Kentucky had existing laws that provide an immunity defense against claims involving the provision of true emergency care at the scene of an emergency, and certain aspects of the provision of CPR and using AED machines in connection with emergency care and treatment. However, these protections do not extend to all types of conduct. Willful and wanton conduct, which means the complete absence of care of another’s life or conscious disregard for safety, is too extreme and is not protected under these Good Samaritan laws.
New legislation is being used to supplement existing Good Samaritan laws and to ensure that healthcare providers have appropriate protections in the context of COVID-19. As of March 30, 2020, Kentucky adopted a law that explicitly provides COVID-19 immunity under certain conditions. The law applies to healthcare providers giving care or treatment to a COVID-19 patient during Kentucky’s state of emergency, which began March 6, 2020. The immunity defense will be available in cases where personal injury is alleged to result from the healthcare provider’s ordinary negligence. The defense covers providers who acted in good faith and applies to both the care and treatment itself, as well as any act or failure to act in providing or arranging future medical treatment to the patient. The immunity does not apply to egregious actions or inaction that shows a disregard for safety.
The statute includes a specific, non-exclusive list of circumstances that would trigger the immunity.
First, it applies to off-label uses of medication to address COVID-19, including both prescribing and dispensing. The provider’s actions must be consistent with the federal Right to Try Act; and KRS 217.5401 to 217.5408, which are Kentucky’s existing requirements for experimental treatments for terminal illnesses.
Second, it covers healthcare services outside of the provider’s professional scope of practice, so long as those services are performed at the request of healthcare facilities or public health entities. The law also permits state medical practice boards to waive scope of practice requirements.
Third, the immunity shelters the use of equipment or supplies outside of the scope of the product’s normal use.
These examples are those specifically described by the legislature, but this is not an exclusive list. Other circumstances may merit the defense. A key factor, though, will be establishing that – regardless of the particular scenario – the provider still followed the standard of care, which means what an ordinary, reasonable, and prudent healthcare provider would do under similar circumstances.
Federal law, too, has implemented COVID-19 immunity-type protections for limited circumstances. Section 3215 of the Coronavirus Aid, Relief, and Economic Security (CARES) Act protects volunteer healthcare professionals from liability harm arising out of the provision of healthcare services for COVID-19 during the federal state of emergency. But this protection only applies to volunteers, and the healthcare professional must be acting in the scope of his or her license. The CARES Act immunity does not apply to egregious conduct or to healthcare services rendered when the provider is under the influence of drugs or alcohol. This protection began March 27, 2020 and only lasts through the national public health emergency.
In addition, the federal Department of Health and Human Services issued a declaration, effective February 4, 2020, that the COVID-19 pandemic falls under the auspices of the Public Readiness and Emergency Preparedness (PREP) Act. The PREP Act gives immunity for claims from the use of countermeasures, that is, drugs and devices used to combat the COVID-19 pandemic in accordance with their FDA-approved uses or investigational or emergency use authorizations. Like the other forms of immunity discussed in this article, the PREP Act immunity does not cover willful misconduct. This immunity only applies in connection with the covered drugs and devices and does not run the gamut of healthcare services.
The importance and impact of the work undertaken by front line service providers during this pandemic cannot be overstated. They are jumping into a continually evolving problem with a widespread effect on Kentucky’s population while putting themselves at risk for infection. These new immunity laws reinforce and reflect the essential nature of that work.