While the Texas Legislature passed stronger liability protections in Senate Bill 6, giving physicians breathing room to respond to a pandemic emergency, federal liability protections installed since the beginning of the COVID-19 pandemic also give doctors some latitude and peace of mind – specifically, around COVID-19 testing, drug treatment, and vaccinations.
TMA’s Office of the General Counsel says the main federal liability protection law that applies to COVID-19, or any other pandemic emergency, is the Public Readiness and Emergency Preparedness (PREP) Act. The PREP Act protects professionals involved in the use, manufacturing, distribution, and administering of certain medical products to combat a public health emergency. Those products, known in legal-speak as “covered countermeasures,” can include vaccines, drugs, medical devices, and more.
Although the law has been in existence since 2005, it’s only activated if the secretary of the U.S. Department of Health and Human Services (HHS) determines a disease or health threat constitutes a public health emergency and then makes a PREP Act declaration. In doing so, the secretary identifies what types of professionals are protected and which products are covered.
According to HHS, a declaration by the secretary “provides immunity from liability … for claims of loss caused by, arising out of, relating to, or resulting from the administration or use of covered countermeasures to diseases, threats, and conditions identified in the declaration.” The only exception to that immunity, TMA’s general counsel’s office says, is a federal lawsuit for death or serious physical injury that’s attributable to willful misconduct.
At the outset of the pandemic, the secretary declared that COVID-19 tests, drugs, and eventual vaccines would be covered under the PREP Act, as would physicians who may administer them. (HHS has now amended the law at least eight times since the start of the pandemic, including to protect more types of professionals for COVID-related activity.)
The HHS secretary’s COVID-19 declaration applies retroactively to Feb. 4, 2020, and is in effect until Oct. 1, 2025. More information about the PREP Act is available on the HHS website.