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Immunity Declared For Entities Fighting COVID-19 Immunity Declared For Entities Fighting COVID-19

Immunity Declared For Entities Fighting COVID-19

NOTE: An updated article on this topic was published on August 6, 2020. Click here to view that updated article.

On March 17, 2020, the Health and Human Services Department issued a Declaration, under the Public Readiness and Emergency Preparedness Act (PREP Act), providing immunity to certain qualified individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures against COVID-19, except for claims involving “willful misconduct.”

Who Is A Covered Person? The Declaration affords liability immunity to manufacturers[1], distributors[2], program planners, qualified persons, and their officials, agents, and employees, as those terms are defined in the PREP Act and the United States. The Declaration also affords liability immunity to any person authorized with the public health and medical emergency response in that jurisdiction to prescribe, administer, deliver, distribute, or dispense the covered countermeasures and their officials, agents, employees, contractors, and volunteers.

What Is A Covered Countermeasure? A covered countermeasure is any antiviral, drug, biologic (i.e., produced from living organisms or containing components of living organisms), diagnostic, device, or vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19. A covered countermeasure also includes any device used in the administration of any such product and all components and constituent materials of any such product. The covered countermeasures must also be qualified pandemic or epidemic products or security countermeasures. 

A qualified pandemic or epidemic product means a drug or device that is  
  1. 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;
  2. 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; or
  3. a product or technology intended to enhance the use or effect of such a drug, biological product, or device.
A security countermeasure is a drug or device that
  1. (a) the Secretary of HHS determines to be a priority to diagnose, mitigate, prevent, or treat harm from any biological, chemical, radiological, or nuclear agent identified as a material threat by the Secretary of Homeland Security, or

    (b) to diagnose, mitigate, prevent, or treat harm from a condition that may result in adverse health consequences or death and may be caused by administering a drug, biological product, or device against such an agent; and
  2. is determined by the Secretary of HHS to be a necessary countermeasure to protect public health.
A qualified pandemic or epidemic product or a security countermeasure must also be approved or cleared under the Food, Drug, and Cosmetic Act (FD&C Act), authorized for emergency use under the FD&C Act, or licensed under the Public Health Service Act. In certain situations, a qualified pandemic or epidemic product may qualify for an exemption; you should contact an attorney if you have questions about whether your product may qualify.

When Does Liability Immunity Apply?  Any liability immunity under the Declaration is likely to be fact-sensitive. For liability immunity to apply under the Declaration, the alleged claim or loss must be caused by or otherwise arise out of, relate to, or result from the medical countermeasures against COVID-19. So, for example, a liability claim for a slip-and-fall injury at a countermeasure distribution program or site that relates to the management and operation of the program or site might be precluded. But a liability claim for a slip-and-fall injury that was not directly related to the countermeasure activities would probably not be precluded. 

How Long Does Liability Immunity Extend? Currently, liability immunity under the Declaration extends through October 1, 2024 – over 4½ years – and even longer if any given product is “obtained for the Strategic National Stockpile.”

Ice Miller attorneys stand ready to assist if you think you or your business may qualify for liability immunity under this Declaration. Contact the Ice Miller COVID-19 Task Force for more information.

This publication is intended for general information purposes only and does not and is not intended to constitute legal advice. The reader should consult with legal counsel to determine how laws or decisions discussed herein apply to the reader’s specific circumstances.
 
[1] A manufacturer includes a contractor or subcontractor of a manufacturer; a supplier or licenser of any product, intellectual property, service, research tool or component or other article used in the design, development, clinical testing, investigation or manufacturing of a Covered Countermeasure; and any or all the parents, subsidiaries, affiliates, successors, and assigns of a manufacturer.
[2] A distributor means a person or entity engaged in the distribution of drugs, biologics, or devices, including but not limited to:  manufacturers; re-packers; common carriers; contract carriers; air carriers; own-label distributors; private-label distributors; jobbers; brokers; warehouses and wholesale drug warehouses; independent wholesale drug traders; and retail pharmacies.
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