Overview

A Notice of Declaration by the Secretary of the Department of Health and Human Services, effective February 4, 2020, provides limited liability immunity for activities covered persons take involving covered countermeasures used in the battle against COVID-19.

Is your business immune from liability?  Have you taken the necessary steps?

“Covered persons” include:

  • Manufacturers
  • Distributors
  • Program planners
  • “Qualified persons”

“Covered countermeasures” include drugs, biologics or devices that are used for COVID-19 and that are

  • approved, licensed or cleared by the FDA;
  • authorized under an FDA Emergency Use Authorization (EUA);
  • described in a CDC Emergency Use Instruction (EUI); or
  • used under either an Investigational New Drug (IND) application or an Investigational Device Exemption (IDE).
Barred Claims
  • Claims that allege an injury caused by or relating to the administration or use by an individual of a covered countermeasure.
  • Claims that are due to the manufacture, delivery, distribution, dispensing, or management and operation of countermeasure programs at distribution and dispensing sites.
Claims Not Barred
  • With limited exceptions, no immunity is available for death or serious physical injury caused by the willful misconduct of a covered person.
  • Federal enforcement actions.
  • Federal law claims for equitable relief.
  • Foreign claims without a link to the United States.
Immunity Coverage Duration
  • Immunity is available through the final day the emergency declaration is in effect or October 1, 2024, whichever occurs first.
  • An additional 12 months of immunity is available to allow manufacturers to arrange for the disposition or return of the covered countermeasure.
Other Declaration Provisions
  • A covered person using or administering a covered countermeasure should document the reasonable precautions they have taken to safely use the covered countermeasure.
  • A countermeasures injury compensation program is available to compensate for injury or death.
For More Information

Please contact Z. Ileana Martinez.