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 covered countermeasure.
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.
McGuireWoods’ COVID-19 Response Team helps clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.