HHS Declaration of COVID-19 Immunity from Suit as Public Health Emergency
For a long while, both Illinois and Indiana have had state laws on the books limiting the financial liability of health care providers for their medical malpractice. Statutory caps on total awards in medical malpractice claims were part of the national tort reform wave of legislation that began in the mid-1970s. For more, read Nelson LJ 3rd, Morrisey MA, Kilgore ML, “Damages caps in medical malpractice cases,” Milbank Q. 2007; 85(2):259–286.
Victims of medical errors in Indiana and Illinois have to work within these statutory frameworks regarding things like limitations deadlines and the amount of non-economic damages available to them under state statutory definitions. See, e.g.,
- Military Medical Malpractice Claims in Illinois or Indiana;
- Medical Malpractice: Injury or Death from Medical Devices; and
- Medical Malpractice in Illinois and Indiana: Botched Surgeries, Nursing Home Neglect, and More.
Now, the federal government is providing immunity from legal liability to health care providers in both Indiana and Illinois as part of the fight against COVID-19.
Coronavirus Immunity Granted in HHS Declaration
In the face of the current Coronavirus Pandemic, Secretary of the Department of Health and Human Services (“HHS”) Alex Azar has issued a federal “Declaration under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19” (“Coronavirus Declaration”).
What is the federal Coronavirus Declaration?
This agency declaration provides a protective umbrella to all lawsuits and liability under powers granted to the HHS by the Public Readiness and Emergency Preparedness Act (“PREP Act”), itself an amendment to the Public Health Services Act (42 U.S.C. 247).
Essentially, the Coronavirus Declaration grants immunity from liability — except in cases of “willful misconduct” and other defined limitations — to “certain individuals and entities” related to their undertaking “critical countermeasures” to fight the Covid-19 pandemic.
What is the Scope of the Coronavirus Declaration Immunity?
The Declaration applies to “…suit and liability under federal and state law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration to or use by an individual of a covered countermeasure.” Under this federal mandate “courts must dismiss claims for any loss that is related to any stage of design, development, testing, manufacture, labeling, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure recommended in a Declaration. This includes, but is not limited to, claims for:
- death;
- physical, mental, or emotional injury, illness, disability, or condition or fear of any such injury, illness, disability, or condition;
- any need for medical monitoring; or
- property damage or loss, including business interruption loss.“
See, Coronavirus Declaration, Section IV and HHS Public Health Emergency PREP Act Q&As.
The Coronavirus Declaration states on its face that it is providing protection against the filing of legal claims as well as legal liabilities in both federal and state jurisdictions.
What is a Covered Countermeasure?
The PREP Act defines the term “Covered Countermeasure” used in the Coronavirus Declaration. These are either (1) a “qualified pandemic or epidemic product;” (2) a defined “security countermeasure;” or (3) a drug, biological product or device authorized for emergency use in accordance with Sections 564, 564A, or 564B of the FD&C Act. For more detail, the Declaration goes into descriptions of each of these categories.
For instance, a “qualified pandemic or epidemic product” is defined as “a drug or device, as defined in the FD&C Act or a biological product, as defined in the PHS Act that is (i) manufactured, used, designed, developed, modified, licensed or procured to diagnose, mitigate, prevent, treat, or cure a pandemic or epidemic or limit the harm such a pandemic or epidemic might otherwise cause; (ii) manufactured, used, designed, developed, modified, licensed, or procured to diagnose, mitigate, prevent, treat, or cure a serious or life-threatening disease or condition caused by such a drug, biological product, or device; (iii) or a product or technology intended to enhance the use or effect of such a drug, biological product, or device.”
See, Coronavirus Declaration, Section VI.
The Coronavirus Declaration defines a far-reaching range of products and services that are covered under its umbrella which are involved in the care and treatment of COVID-19 victims.
Who is Provided Immunity under the Coronavirus Declaration?
Not everyone gets this emergency immunity protection under federal law. To qualify, the provider must meet the definition of “Covered Persons” under the PREP Act. However, the definitions provided are expansive, and many health care providers (individuals and entities) will consider themselves to be within them.
The term “Covered Persons” is defined to “… include manufacturers, distributors, program planners, and qualified persons, and their officials, agents, and employees, and the United States.”
Each of these terms is given specific descriptions within the Declaration’s language. For example, “qualified person” is defined as “…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; or a person within a category of persons identified as qualified in the Secretary’s Declaration. Under this definition, the Secretary can describe in the Declaration other qualified persons, such as volunteers, who are Covered Persons.”
See, Coronavirus Declaration, Section V.
The Coronavirus Declaration covers not only doctors and hospitals, but others involved in health care including wholesale drug warehouses and those involved in clinical testing. A wide variety of individuals and entities are covered within its definition’s four categories of “Covered Persons.”
Limitations to the Coronavirus Declaration’s Immunity from Suit and Liability
There are exclusions to the Immunity provided in the Coronavirus Declaration. These include the following:
1. Willful Misconduct
The Coronavirus Declaration does not apply to claims involving “willful misconduct” as defined in the PREP Act. Under the PREP Act, “willful misconduct” means misconduct that is greater than any form of recklessness or negligence.
Proven by clear and convincing evidence, “willful misconduct” will not be protected by the Coronavirus Declaration, involving 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 or obvious risk that is so great as to make it highly probable that the harm will outweigh the benefit.
However, under the PREP Act, “willful misconduct” cannot be found against:
- A manufacturer or distributor for actions regulated by HHS under either the Public Health Service Act or the Federal Food, Drug and Cosmetic Act, if (a) HHS chooses not to take an enforcement action against the manufacturer or distributor, or (b) if HHS terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty; and
- A program planner or qualified person who acts in accordance with applicable directions, guidelines, or recommendations issued by the HHS regarding administration and use of a countermeasure as long as either the (a) HHS, (b) the State, or (c) local health authority is notified about the serious injury or death within seven (7) days of its discovery.
See, Coronavirus Declaration, Supplementary Information and HHS Public Health Emergency PREP Act Q&As.
2. Activities Outside the Declaration Definitions
Only the specific measures defined within the Coronavirus are covered by the immunity provisions of the Declaration, according to HHS: “…immunity is not available for claims based on activities that fall outside the scope of the applicable Declaration.” This includes things like effective dates and defined geographic areas.
Moreover, the Declaration’s immunity is “not available for claims of loss unrelated to the design, development, testing, manufacture, labeling, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure recommended in a Declaration.”
See, HHS Public Health Emergency PREP Act Q&As.
3. Foreign Claims
The Coronavirus Declaration by definition cannot apply to foreign claims. “Immunity is not available where the U.S. has no jurisdiction.”
See, HHS Public Health Emergency PREP Act Q&As.
Coronavirus Medical Error and Malpractice Claims in Indiana and Illinois
Of course, those who are on the front lines of the battle against the novel Coronavirus as well as those attempting to find ways to treat or to cure this unprecedented infection are today’s heroes as they risk their lives each day. The Coronavirus Declaration is designed to help them by removing the burden of legal exposure as they move through these uncharted waters.
However, there will still be medical errors and mistakes causing the deaths of innocent victims in Indiana and Illinois during this Pandemic.
- Unrelated to COVID-19, arguments must be made that these victims and their loved ones still have the ability to pursue legal claims for justice under existing medical malpractice or defective products laws.
- Additionally, there are also considerations to be made of “willful misconduct” during this Pandemic that are exceptions to the application of the Coronavirus Declaration.
- Moreover, there is a consideration of where the line is drawn for “covered persons.” Will nursing homes known to have a history of substandard care be able to use the Coronavirus Declaration as a shield to liability?
Botched surgeries, misdiagnoses, and other medical mistakes can have catastrophic consequences for both the malpractice victim and his loved ones. Please be careful out there!
