PREP Act Questions and Answers

A Declaration may provide liability immunity for covered persons.  Covered persons may include, at the Secretary’s discretion:

• Manufacturers of countermeasures;
• Distributors of countermeasures;
• Program planners, i.e., individuals and entities involved in planning, administering, or supervising programs for distribution of a countermeasure (e.g., State or local governments, Indian tribes, or private sector employers or community groups that establish requirements or provide guidance, technical or scientific advice or assistance, or provide a facility);
• Qualified persons, i.e., persons who prescribe, administer, or dispense countermeasures such as healthcare and other providers or other categories of persons named in a Declaration, e.g., volunteers;
• Officials, agents, and employees of any of these entities or persons; and
• The United States.
  

In deciding whether to issue a PREP Act Declaration, HHS must consider the desirability of encouraging the design, development, clinical testing or investigation, manufacture, labeling, distribution, formulation, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administering, licensing, and use of the countermeasure recommended in the Declaration. HHS may also consider other relevant factors.

Under section 319 of the Public Health Service Act, HHS may issue a declaration of a public health emergency based upon a determination that a:

• disease or disorder presents a public health emergency; or
•  public health emergency, including significant outbreaks of infectious disease or bioterrorist attacks, otherwise exists.

Following a section 319 declaration, the HHS can take a number of emergency actions, including:

• Waiving certain Medicare, Medicaid, State Children's Health Insurance Program, and Health Insurance Portability and Accountability Act requirements;
• Allowing States and localities to temporarily reassign personnel supported with federal funds during the period of the emergency.

A determination of a public health emergency is different from a PREP Act declaration.  The declarations are made on different public health determinations, and have different legal effects.   A PREP Act Declaration may be made in advance of a public health emergency and may provide liability immunity for activities both before and after a declared public health emergency.  A separate declaration under section 319 or other statutes is not needed for immunity under the PREP Act to take effect unless the PREP Act Declaration states that a public health or other emergency Declaration is needed to trigger immunity.

Immunity means that courts must dismiss claims brought against any entity or individual covered by the PREP Act.  Claims that courts must dismiss include 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.

The only exception is for claims of willful misconduct.  (See Question: Are There Any Limitations on Immunity From Liability?).

A Declaration may provide liability immunity for covered persons.  Covered persons may include, at the Secretary’s discretion:

• Manufacturers of countermeasures;
• Distributors of countermeasures;
• Program planners, i.e., individuals and entities involved in planning, administering, or supervising programs for distribution of a countermeasure (e.g., State or local governments, Indian tribes, or private sector employers or community groups that establish requirements or provide guidance, technical or scientific advice or assistance, or provide a facility);
• Qualified persons, i.e., persons who prescribe, administer, or dispense countermeasures such as healthcare and other providers or other categories of persons named in a Declaration, e.g., volunteers;
• Officials, agents, and employees of any of these entities or persons; and
• The United States.
  

Immunity from liability under the PREP Act is not available for death or serious physical injury caused by willful misconduct.  A “serious physical injury” is one that is life-threatening, or results in or requires medical or surgical intervention to preclude permanent impairment of a body function or results in permanent damage to a body structure.  Willful misconduct is misconduct that is greater than any form of recklessness or negligence.  It is defined in the PREP Act as an act or failure to act that is taken:

• intentionally to achieve a wrongful purpose;
• knowingly without legal or factual justification; and
• 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.  All three of these conditions must be proven with clear and convincing evidence.  Willful misconduct cannot be found against:
• A manufacturer or distributor for actions regulated by HHS under the Public Health Service Act or the Federal Food, Drug and Cosmetic Act, if HHS chooses not to take an enforcement action against the manufacturer or distributor, or if HHS terminates or settles an enforcement action without imposing a criminal, civil, or administrative penalty; or
• 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 HHS or the  State or local health authority is notified about the serious injury or death within seven days of its discovery.

 In addition, immunity is not available for claims based on activities that fall outside the scope of the applicable Declaration.  As described below (5. “When Does Immunity Under the PREP Act Become Available?”), the Declaration can specify the conditions under which a Declaration will provide immunity, such as the effective dates and geographic area for which immunity will be available.  Immunity is not available for claims that fall outside these conditions.

Immunity is not available for claims of loss unrelated to the design, development, testing, manufacture, distribution, formulation, labeling, packaging, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of a countermeasure recommended in a Declaration.

Immunity from liability also is not available for foreign claims where the U.S. has no jurisdiction.  Immunity may be available for administration or use of a countermeasure outside the United States if the claim is based on events that take place in U.S. territory or there is another link to the U.S. that makes it reasonable to apply U.S. law to the claim.

In addition, immunity is not available for claims based on activities that fall outside the scope of the applicable Declaration.  As described below (5. “When Does Immunity Under the PREP Act Become Available?”), the Declaration can specify the conditions under which a Declaration will provide immunity, such as the effective dates and geographic area for which immunity will be available.  Immunity is not available for claims that fall outside these conditions.

A “covered countermeasure” may be:

• A qualified pandemic or epidemic product;
• A security countermeasure;
• An unapproved drug, biological product, or device used under an Emergency Use Authorization (EUA) issued by FDA;
• An approved drug, biological product, or device  used pursuant to Federal law in conditions that are in  consistent with its approval ; or
• An unapproved drug, biological product, or device, or an approved drug, biological product, or device intended for an unapproved use, that is intended for emergency use and shipped and held by a government agency or someone working on that agency’s behalf for  use only when that use is authorized.

In general, these are products that are approved, cleared, or licensed by FDA; authorized for investigational use, i.e. an Investigational New Drug (“IND”) or Investigational Device Exemption (“IDE”), by FDA, authorized under an EUA by FDA, or otherwise permitted to be held or used for emergency use in accordance with Federal law.  However, each has a specific legal definition.  See the PREP Act Glossary for more information.

Immunity under the PREP Act becomes available when HHS issues a Declaration, beginning on the effective date or other triggering event stated in the Declaration.  For example, the Declaration may specify that activities such as manufacture and testing are covered on the effective date of the Declaration, but emergency uses such as mass dispensing are covered following a declared public health or other emergency.

The PREP Act authorized a “Covered Countermeasures Process Fund” to compensate eligible individuals who suffer injuries as the direct result of a countermeasure administered or used under the Declaration.  Funds must be appropriated by Congress into this account to pay claims.  If funds are appropriated, compensation for serious physical injuries may then be available to eligible requesters under the HRSA’s Countermeasures Injury Compensation Program (CICP).  Requests for Benefits must be made to HRSA’s CICP.

Serious physical injury means an injury that warranted hospitalization (whether or not the person was actually hospitalized) or that led to a significant loss of function or disability.  The CICP pays reasonable and necessary medical benefits, and/or lost wages for eligible injured countermeasure recipients.  Death benefits may also be available to certain survivors of eligible individuals who died as a direct result of the administration or use of a covered countermeasure.

The CICP is payer of last resort, so benefits are reduced by the amounts payable by all other public and private third-party payers (such as health insurance and workers’ compensation).  The regulations implementing the CICP are at 42 CFR part 110.

An individual who may have suffered a serious physical injury from the administration or use of a countermeasure under a Declaration may seek compensation by filing a Request for Benefits with the CICP.  A Request for Benefits form must be filed within one year of receiving the countermeasure.

A legal or personal representative may file on the individual’s behalf, but is generally not required unless the injured person is a minor or an adult who lacks legal capacity to receive payments.  If the injured person has died (regardless of cause of death), the executor or administrator of the estate may file for benefits on behalf of the estate.  If the injured person died as a direct result of receiving the countermeasure, certain survivors may file a request for death benefits.

As well as filing a Request for Benefits Form,  the requester must submit all required medical records and other supporting documentation.  Further information on filing a Request for Benefits is available on the CICP’s website.

If no funds have been appropriated to the compensation program, or the Secretary does not make a final determination on the individual’s request within 240 days, or the individual decides not to accept the compensation, the injured individual or his representative may pursue a tort claim in the United States District Court for the District of Columbia, but only if the claim involves willful misconduct and meets the other requirements for suit under the PREP Act. If the individual accepts compensation from the CICP, or if there is no willful misconduct, the individual does not have a tort claim that can be filed in a United States Federal or a State court.

Any award is reduced by public or private insurance or worker’s compensation available to the injured individual. Awards for non-economic damages, such as pain, suffering, physical impairment, mental anguish, and loss of consortium are also limited.

On November 21, 2012, the Appellate Division of the New York Supreme Court in Parker v. St. Lawrence County Public Health Department, 102 A.D.3d 140 (2012) upheld PREP Act protections for a county that conducted a school based vaccination clinic in response to the H1N1 outbreak.

During the clinic, a nurse employed by St. Lawrence County inadvertently vaccinated a kindergartener in the absence of parental informed consent.  The child's mother filed suit, arguing that the county had committed negligence and battery.  The county moved to dismiss the complaint on the basis that the claim was preempted under the PREP Act.  The lower court denied the defendant's motion to dismiss, asserting that the PREP Act was not intended by Congress to protect against claims arising from failure to obtain informed consent. The county appealed and the United States submitted an amicus brief supporting the county.

The appellate court dismissed the plaintiff's claims, finding that the federal PREP Act preempted the claims under state law and that the breadth of liability immunity provided under the PREP Act precluded the plaintiff's claims of negligence and battery.  The court noted the alternative remedy provided by the countermeasure injury compensation program and the possibility of a federal cause of action for willful misconduct claims.

The period for appeal of the case has expired.

In another case, Kehler v. Hood, 2012 WL 1945952 (E.D.Mo.), plaintiffs alleged that the physician and her employing hospital were negligent in failing to obtain the adult patient’s informed consent and a consult from a specialist prior to the administration of the vaccination, which resulted in a severe case of transverse myelitis to the patient, and  loss of consortium to the spouse.  Defendants then brought third party product liability/failure to warn claims against the manufacturer.

The parties did not dispute that the manufacturer, was protected by the PREP Act, nor did they allege that it engaged in willful misconduct.  As a result, the federal Eastern District Court of Missouri dismissed the claim against the manufacturer.  Finding that it had no jurisdiction over plaintiffs’ remaining claims, the federal court remanded the case to state court for further consideration of the plaintiffs’ claims.

The end of the PHE does not automatically terminate PREP Act coverage for activities related to COVID-19 Countermeasures.  Manufacturers, distributors, public and private entities conducting countermeasure programs and providers authorized under state law or by the Secretary’s PREP Act declaration for COVID -19 countermeasures are covered (subject to the terms of the Act and the declaration):

• For all activities related to a federal agreement through October 1, 2024 (for example, a federal contract for procurement and distribution of vaccines or treatments, provider agreement; memorandum of understanding, etc.);
• For all activities not related to a federal agreement (e.g., countermeasures distributed entirely through the commercial sector or as part of a state emergency response) through October 1, 2024, or the end of any federal, regional, state, or local declared emergency, whichever is first;
• For activities related to products distributed from the Strategic National Stockpile until they are used;
• For activities related to NIOSH-regulated masks for as long as the Secretary determines the products are needed to respond to the PHE.
  

Thus, under the terms of the current PREP Act declaration for COVID -19 countermeasures, PREP Act coverage will end if the PHE and all other emergency declarations end, and there is no federal agreement relevant to the activity.

Whether a person (e.g., a pharmacist) can prescribe a “covered countermeasure” as a treatment for COVID-19 is governed by the terms of the Emergency Use Authorization for an authorized product. Covered countermeasures, including therapeutics, are defined in the PREP Act as products that are authorized, approved, licensed, or cleared by FDA. 42 U.S.C. 247d-6d(i)(1),(7). Section V(i) of the Secretary’s PREP Act Declaration for COVID-19 Countermeasures, added in the Ninth Amendment to the Declaration at 86 FR 51160 (September 14, 2021), authorizes pharmacists to order (i.e., prescribe) and administer COVID-19 therapeutics that fall within the definition of “covered countermeasure” under the Act, including countermeasures that are authorized by FDA. The same amendment also authorizes pharmacists, pharmacy technicians, and pharmacy interns to administer (but not order) authorized COVID-19 therapeutics under certain conditions. Importantly, the declaration also specifies that the ordering and administration of authorized therapeutics must be done in accordance with the FDA authorization of the product.

Specifically, section V(i) of the declaration provides that the following persons are qualified persons to order and administer COVID-19 therapeutics that are authorized, approved, licensed, or cleared by FDA, provided certain conditions are met, including:

9. The COVID-19 therapeutic must be authorized, approved, licensed, or cleared by the FDA;
10. In the case of a licensed pharmacist ordering a COVID-19 therapeutic, the therapeutic must be ordered for subcutaneous, intramuscular, or oral administration and in accordance with the FDA approval, authorization, or licensing;
11. In the case of licensed pharmacists, qualified pharmacy technicians, and licensed or registered pharmacy interns administering the COVID-19 therapeutic, the therapeutic must be administered subcutaneously, intramuscularly, or orally in accordance with the FDA approval, authorization, or licensing;…” Ninth Amendment to the Secretary’s PREP Act Declaration for COVID-19 Countermeasures, 86 FR 51160 (September 14, 2021).

Accordingly, under the Ninth Amendment to the Secretary’s PREP Act Declaration, a pharmacist is only allowed to order COVID-19 therapeutics (and pharmacists, pharmacy technicians, and interns are only allowed to administer COVID-19 therapeutics) under the terms of the FDA Emergency Use Authorization issued for that product. For example, if the Emergency Use Authorization includes a condition that the product may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which the belongs, the Ninth Amendment to the Secretary’s PREP Act Declaration would not permit pharmacists to order the product.  Additionally, if the Emergency Use Authorization specifies conditions under which a product may be prescribed by pharmacists, then the Ninth Amendment to the Secretary’s PREP Act Declaration would only permit pharmacists to order the product when the conditions specified in the Emergency Use Authorization are met.