Key Points

  • HHS Declaration Provides Immunity: During a public health emergency, the Secretary of HHS can issue a Declaration providing broad tort immunity for “Covered Persons” engaging in “Recommended Activities” with “Covered Countermeasures.”
  • Covered Persons: The entities covered include, among others, manufacturers and distributors.
  • Recommended Activities: Under the Declaration, the activities covered include “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.”
  • Covered Countermeasures: This will include diagnostics, treatment, vaccines and other prevention modalities, masks and other medical equipment that are FDA-approved or cleared, licensed under the PHS Act, or authorized for emergency use by the FDA. Note that NIOSH-approved masks are now included.
  • Willful Misconduct: This is not protected by the Act.
  • FDA Loosens EUA Requirements: Given the shortage of materials, especially masks, the FDA has indicated that it wants to help applicants through their EUA process, even if they are new to medical device manufacturing. In other words, if