COVID And Immunity From Liability Under The Federal PREP Act

Under the Federal PREP Act, immunity from liability can be extended to those who respond to an epidemic or pandemic. Unfortunately, the definitions, requirements, and exemptions within the PREP Act are very complex and redundant – often referencing language in other laws that, in turn, reference definitions or requirements contained in sections of still other laws. Much of my legal practice involves contract reviews and it took me nearly 8 hours to read through the PREP Act, the accompanying Declaration by Secretary Alex Azar, and the pertinent language in all the statutes referenced in those documents to summarize exactly what is and is not covered under the Act.

Federal PREP Act Background

The Public Readiness and Emergency Preparedness Act (PREP Act) was enacted in 2005 to provide limited liability protections to those “Covered Persons” who use “Covered Countermeasures” in response to a pandemic or epidemic.

The protections afforded by the PREP Act are not always active. Instead, implementation of the PREP Act is dependent upon several actions that must be taken by the Secretary of the Department of Health and Human Services. For example, the Secretary must declare that some threat to public health constitutes either an actual public health emergency or a credible risk of creating public health emergency. Without such a declaration, the immunity provided in the PREP Act don’t materialize. Under the PREP Act, the Secretary must also define the scope of activities that will receive immunity under the Act, who is eligible to receive the immunity, the immunity provided, the populations and geographic areas covered by the declaration, and the duration for which the immunity is in effect. Under 42 USC § 247d-6d(d), the only exception to liability under the Act is that if a “covered person” acts with willful misconduct (a standard higher than negligence or recklessness) and causes death or serious injury.

How Does the PREP Act Apply to COVID?

On March 10, 2020, Secretary of Health and Human Services Alex Azar issued a “Declaration under the PREP Act for medical countermeasures against COVID-19” to be published in the Federal Register which created liability immunity to a group of “Covered Persons.” The full text of the declaration can be found at this link: https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx.

My attempt at a summary of the Declaration is below.

Who Are “Covered Persons” Under The PREP Act?

This is where the language gets confusing. The Declaration states that “Covered Persons who are afforded liability immunity under this Declaration are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, as those terms are defined in the PREP Act, and the United States.” This means you have to look up how each of “those terms” are defined in the PREP Act. I’m going to just focus upon the medical provider aspect of the Act.

“Covered Persons” who receive immunity under Secretary Azar’s Declaration include anyone authorized to “prescribe, administer, deliver, distribute or dispense the Covered Countermeasures, and their officials, agents, employees, contractors and volunteers.” The Declaration also includes anyone who uses “Covered Countermeasures” under Section 564 of the Food, Drug, and Cosmetic Act. A review of the FD&C Act shows that it grants Emergency Use Authorizations to unapproved medical products and devices or the use of approved medical products in unapproved ways to diagnose, treat, or prevent serious diseases or conditions. Read about the Emergency Use Authorization in this 49-page FDA set of guidelines if that’s your thing: https://www.fda.gov/media/97321/download.

We’re not done yet. “Covered Persons” also have to be “authorized in accordance with the public health and medical emergency response of the Authority Having Jurisdiction.” The Declaration vaguely defines the term “Authority Having Jurisdiction” as “the public agency or its delegate that has legal responsibility and authority for responding to an incident.” It appears that the Department of Health and Human Services is the “Authority Having Jurisdiction” in this case, but the Authority may also be Federal and State licensing agencies as they can be “delegates” of HHS. Ready to get off the merry-go-round yet?

The preamble to Secretary Azar’s Declaration specifically states that “A qualified person means a licensed health professional or other individual authorized to prescribe, administer, or dispense Covered Countermeasures under the law of the state in which the Covered Countermeasure was prescribed, administered, or dispensed.”

Bottom Line: There are many categories of “Covered Persons” under Secretary Azar’s Declaration. All licensed medical providers appear to be considered “Covered Persons” for purposes of the PREP Act.

What Activities Are Covered Under The PREP Act?

The Declaration only applies to Covered Persons when they use “Covered Countermeasures.” The text of the Declaration defines “Covered Countermeasures” as “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 used to decrease 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.”

This language is expansive but fairly straightforward. Any diagnostic or device to treat/diagnose/cure/prevent/mitigate COVID-19 is “Covered.” Such a definition could apply to innovative designs for masks or makeshift ventilators. I’m thinking of all you 3-D printer gurus out there. The definition also applies to approved or unapproved medications, medical testing, and medical procedures – even if experimental – as long as they are used to battle COVID.

But … the Declaration also states that “Covered Countermeasures” must be “qualified pandemic or epidemic products,” “security countermeasures,” or “drugs, biological products, or devices authorized for investigational or emergency use, as those terms are defined in the PREP Act, the FD&C Act, and the Public Health Service Act.” Back to the statutes.

A “qualified pandemic or epidemic product” is defined under Section (i)(7) of the PREP Act (42 USC § 247d-6d(i)(7)). This definition includes references to 12 other sections of various laws. I’m not kidding. Essentially a “qualified pandemic or epidemic product” is any drug, biologic, or device that is created or used in any way to diagnose, mitigate, prevent, treat, or cure a pandemic, or to limit harm a pandemic or epidemic might otherwise cause. The definition also includes any product that enhances the effects of, or counters any serious or life-threatening condition caused by “qualified pandemic or epidemic products.”

A “security countermeasure” is defined under 42 USC § 247d–6b(c)(1)(B) of the PREP Act. This definition includes references to only 10 other sections of various laws. A “security countermeasure” is basically the same thing as a “qualified pandemic or epidemic product” but which is determined by the Secretary to be a “priority” and is cleared under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351 et seq.] or is cleared for emergency use under a different section of the Food, Drug, and Cosmetic Act [21 U.S.C. 360bbb–3].

Bottom Line: Immunity under the PREP Act only applies to “Covered Countermeasures” but the definition of a “Covered Countermeasure” includes any drug, biologic (including vaccines), diagnostic test or other device used to treat, diagnose, cure, prevent, or mitigate COVID-19, or used to decrease the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product.

What Activities Are Immune From Lawsuits Under The PREP Act?

This is important. Just because actions (or “countermeasures”) are taken during a pandemic does not mean that those actions qualify for immunity. The PREP Act only applies to “Recommended Activities.” Section III of Secretary Azar’s Declaration defines covered “Recommended Activities” as “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.” The terms “manufacture, testing, development, and distribution” of Covered Countermeasures probably won’t apply to clinical medical care.

The term “administration” is defined in the Declaration as “physical provision of the countermeasures to recipients, or activities and decisions directly relating to public and private delivery, distribution and dispensing of the countermeasures to recipients, management and operation of countermeasure programs, or management and operation of locations for purpose of distributing and dispensing countermeasures. If an injury is caused by a Covered Countermeasure, is due to manufacture or distribution of a Covered Countermeasure, or results from management and operation of a Covered Countermeasure program, immunity is provided under the PREP Act.

To be immunized, the activities must DIRECTLY RELATE to countermeasure activities. The preamble to the Declaration gives several examples of immunized activities including vaccine manufacture, inadvertent negligence in prescribing of medications by a physician, slip and fall injuries at countermeasure sites, allegations of lax security at such sites, or motor vehicle collisions relating to delivery of countermeasures. In contrast, a slip and fall injury in a hospital’s gift shop would probably not be immunized under the PREP Act because it does not “directly relate” to any type of countermeasure. However, if the slip and fall occurred while the person was purchasing masks or hand sanitizer at the gift shop or while staff was cleaning the floor to try to prevent spread of COVID, the immunity under the PREP Act might apply. As Secretary Azar’s Declaration notes, “[i]n each case, whether immunity is applicable will depend on the particular facts and circumstances.” Actions must directly relate to countermeasures to receive immunity under the PREP Act.

Bottom Line: Only activities that DIRECTLY RELATE to COVID countermeasures are immune from liability under the PREP Act. If you are providing care or taking measures to diagnose or prevent COVID in your care of a patient, make sure that fact is mentioned somewhere in your patient’s chart.

What Activities Are NOT Immune From Lawsuits Under The PREP Act?

If an action doesn’t directly relate to COVID countermeasures, it is not immune from liability under the PREP Act. Allegations of liability or immunity will be reviewed on a case by case basis.

I’m speculating that “inaction” isn’t covered by the PREP Act. Failing to take action (as in not going to work at a hospital) may prevent the spread of COVID in some circumstances, but nothing I could find in the language of the Act immunized a failure to act. This discrepancy may be something that legislators need to specifically address in the future. I can’t see the intent of this law to encourage medical professionals NOT to try to help patients.

The only other “Recommended Activity” that isn’t covered is an action taken with willful misconduct. With regard to medical care, a breach of the “standard of care” – which amounts to “medical negligence” – is immunized. Even “recklessness” is immunized under the PREP Act. Willful misconduct is a high burden of proof to meet. Although legal definitions of “willful misconduct” vary, in general willful misconduct means that a person did something that should not be done and knew that the action would probably result in an unjustified injury to another person. Trying a new technique to create ventilator availability or improve oxygenation in patients suffering from COVID is likely going to be a covered “Recommended Activity.” Intentional criminal acts such as giving overdoses of medication to euthanize sick patients and “cull the herd” won’t qualify for immunity under the PREP Act and will get you thrown in prison for a long time.

Bottom Line: The PREP Act only applies to actions that directly relate to battling COVID. It probably does not apply to inaction and definitely does not apply to willful misconduct or intentional acts. Do what you can to help your patients in the COVID crisis and you won’t have to worry about being accused of willful misconduct.

What Immunity From Lawsuits Is Provided Under The PREP Act For COVID-related care?

Section 247d-6d(a)(1) of the PREP Act describes the immunity provided under the Act.

Under the Act, a “Covered Person” is immune from lawsuit or any liability under Federal or State law for any claim of loss relating to administration or use of a “covered countermeasure” once an emergency declaration has been made. Under Section 247d-6d(a)(2), the term “loss” means “any type of loss” and specifically includes death; actual or feared physical, mental, or emotional injuries; and loss/damage to property, including business interruption loss. In all cases, the immunity from liability “applies without regard to the date of the occurrence, presentation, or discovery of the loss described in the clause.”

There are conditions to this immunity, however. Immunity only applies if the “Covered Countermeasure” occurred during the Emergency Declaration and if the countermeasure was used or administered in response to the threat specified in the Declaration (in this case, COVID).

A nice additional protection under the Act is that any administration of use of a “Covered Countermeasure” during the emergency declaration creates a “rebuttable presumption” that the “Recommended Action” is pursuant to the Act and is therefore immune from liability. A “rebuttable presumption” means that an allegation or theory is considered true unless an opposing party can present sufficient evidence to contradict the presumption. In the case of the COVID emergency declaration, a plaintiff alleging that an action was not immunized under the PREP Act because it did not involve a “Covered Countermeasure” would have to provide some factual evidence to prove that point. A simple assertion that an action was not a “Covered Countermeasure” would be insufficient to rebut the presumption to the contrary created by the Statute.

Since I do a lot of administrative law in my legal practice, I considered the question whether immunity under the PREP Act applies to administrative actions taken by State Medical Boards. State Medical Boards are granted power by each individual state’s Medical Practice Act. State Medical Boards are also bound by administrative rules which are codified in State and Federal law. Since powers and actions of State Medical Boards are controlled by Federal and State law and since the PREP Act immunizes any “liability” under Federal or State law, my rebuttable presumption is that the PREP Act also immunizes actions taken by State Medical Boards.

Since the immunity provision specifically mention “business interruption loss,” any medical providers who had to close their offices in order to take affirmative actions to stop the spread of COVID (which would presumably be a “Covered Countermeasure”) may want to inquire what types of business interruption loss may be immunized under the PREP Act.

The PREP Act also raises an interesting question about EMTALA and HIPAA. If the PREP Act immunizes “Covered Persons” from liability under Federal or State law, are “Recommended Actions” taken by medical providers subject to requirements in federal EMTALA and HIPAA laws? I wasn’t able to find any exceptions to EMTALA and HIPAA in the PREP Act. What happens when there is such a significant and direct conflict between federal laws?

Bottom Line: Hypotheticals aside, as long as clinical actions are being taken as a “Covered Countermeasure” to the COVID crisis, chances are good that the actions are immune from liability. Make sure that a patient’s medical record contains a reference to COVID if actions are taken to diagnose, prevent, or treat the disease.

How Long Does Immunity Under The PREP Act Last?

Immunity from liability under the PREP Act doesn’t last forever. Under Section XII of Secretary Azar’s Declaration, immunity from liability for Covered Countermeasures administered and used in medical response to the COVID crisis begins when the Declaration was created (March 10, 2020) and lasts through the earlier of either October 1, 2024 or the last day of the “emergency Declaration” that gave rise to the applicability of the PREP Act. In other words, at some point, the President will make an announcement that the COVID Emergency Declaration is no longer in effect. At that point, immunity under the PREP Act will cease. Watch the news for such an announcement.

Summary

Stay safe, do what you can to help others, and don’t worry about ads like this from law firms:

Now I’m going to go take some ibuprofen for the headache I developed researching this. And yes, ibuprofen is safe – even if you do have a COVID infection.