Under the Public Readiness and Emergency Preparedness Act, the secretary of
the U.S. Department of Health and Human Services can issue a declaration to
provide immunity for individuals and entities from any liability arising
from the manufacture, distribution, prescription and administration of any
A covered countermeasure means any qualified pandemic or epidemic product —
such as a drug, device or biologic product — that may mitigate, treat or
cure a pandemic or epidemic or limit the harm it may cause. This can also
include drugs, devices or biologics that could counteract dangers posed by
other drugs, devices or biologics, and also includes technology that may
enhance the use of a drug, device or biologic.
On Feb. 4, 2020, HHS Secretary Alex Azar
declared immune from liability
countermeasures used to combat COVID-19 until the emergency declaration is
receded or October 1, 2024. Drug and device manufacturers should consider
this when tracking products used to treat COVID-19 symptoms. This can range
from prescription products to treat pain, to products used to treat cough
and cold symptoms.
Protection from future liability depends on tracking adverse events during
this time period and drug utilization and usage in the event a claim
arises. Importantly, the ability to claim immunity from liability does not
extend to willful acts or misconduct. Manufacturers should note which
products this may apply to and note for future liability.
The McGuireWoods team will continue to monitor this situation. Please reach
out to a member of our team with any questions.
COVID-19 Response Team helps clients navigate urgent and evolving legal and business issues
arising from the novel coronavirus pandemic.