The PREP Act Provides Liability Immunity for Injuries Caused by Medical ‘Countermeasures’ Against COVID-19
A few days after President Donald Trump declared a national emergency to combat the coronavirus pandemic, the Secretary of the Department of Health and Human Services (HHS) issued a Declaration revitalizing the PREP Act, which was originally enacted in 2005.
What is the PREP Act?
PREP stands for Public Readiness and Emergency Preparedness. The Declaration under the PREP Act for medical countermeasures against COVID-19 provides legal immunity for manufacturers, suppliers, distributors, and other “covered persons” involved in the manufacture, distribution, and dispensation of products and medical countermeasures used to combat the coronavirus disease.
In other words, the Declaration provides legal protections to covered persons and organizations that manufacture, sell, and distribute:
- qualified pandemic or epidemic products;
- security countermeasures; and
- drugs, devices, or biological products for emergency or investigational purposes.
Who Qualifies for These Protections During the Coronavirus Pandemic?
The government provides liability immunity to qualified individuals and organizations to encourage innovation and expedience, protecting them against a potential product liability case unless the case involves “willful misconduct.”
However, just because the Declaration provides liability immunity to many manufacturers and sellers of qualifying products related to the coronavirus pandemic does not necessarily mean that injured victims cannot recover damages if their injury was caused by defects or inherently dangerous products.
Contact a Morristown product liability attorney to examine your case and determine whether the legal protection will apply. In some cases, the applicability of this protection may be subject to litigation for years.
What Are Covered ‘Countermeasures’ Against COVID-19?
During the coronavirus pandemic, the PREP Act provides immunity from tort liability claims except in cases involving willful misconduct.
Covered countermeasures against COVID-19 include:
- Any drugs, antiviral medications, or vaccine to treat, diagnose, prevent or mitigate the disease; and
- Any diagnostic, pharmaceutical, or other devices against the coronavirus disease (including component parts and constituent materials of such products).
What Immunity Does the PREP Act Provide?
Liability immunity under the PREP Act includes protection from any claim under federal or state law for personal injury, fear of injury, wrongful death, emotional distress, property damage, and business interruption caused by the covered countermeasure.
What conduct qualifies for immunity and which products and services are considered “covered countermeasures” will be determined on a case-by-case basis. Any injured person can challenge the liability immunity by presenting evidence to prove that the defendant is not entitled to immunity under the PREP Act.
The PREP Act supports innovation by healthcare, public health, medical device, and pharmaceutical professionals to fight and prevent the spread of coronavirus by providing liability immunity.
This legal protection allows qualifying individuals and organizations to work under emergency conditions without fear of facing legal action. After all, conduct deemed to be reasonable under emergency conditions – for instance, during the pandemic – can be viewed differently or called into question after time has passed.
However, the application of liability immunity is determined on a case-by-case basis, which is why you need a Morristown personal injury lawyer to consider all qualifying criteria and technical limitations in your particular situation. Reach out to the Law Offices of Michael P. Burakoff, P.A., to schedule a consultation. Call at 973-455-1567 today.