Legal Immunity: A Reward for Innovators Combatting COVID-19

Please note: The below information may require updating, including additional clarification, as the COVID-19 pandemic is dynamic and continues to develop. Please monitor this site and/or your email for updates. 

In light of the public health emergency, the Secretary of Health and Human Services has issued a Notice of Declaration providing immunity from legal liability for activities relating to combatting the new coronavirus.[1] Under the Declaration, certain individuals and entities will be immune from any suit and liability under federal and state law with respect to all claims for loss relating to the manufacture, testing, development, distribution, administration, or use of medical countermeasures against COVID-19 ( “Covered Countermeasures”).[2]

The liability immunity granted by the Declaration is intended to incentivize companies to quickly develop and test new products while protecting them from threats of future liability that may arise from such early actions. Manufacturers, distributors, and health care providers (including their employees, officials, and agents) who perform activities relating to the Covered Countermeasures may qualify for immunity under the Declaration.[3]

In general, to be considered as a Covered Countermeasure under the Declaration, a product should be an antiviral, drug, biologic, diagnostic, device, or vaccine that is: (i) used to treat, diagnose, cure, prevent, or mitigate COVID-19 or the transmission of the new coronavirus; and (ii) authorized for use by the Food and Drug Administration (FDA) or otherwise permitted for emergency use in accordance with Federal law.[4][5]

However, not all medical countermeasures qualify as a Covered Countermeasure. Notably, several N-95 respirators may not qualify as Covered Countermeasures under the Declaration, because they are not FDA-approved but instead regulated by the National Institute for Occupational Safety and Health.[6]  N-95 respirator masks are personal protective equipment used to protect against airborne particles and liquid contamination.  In addition, the immunity does not extend to claims involving willful misconduct.[7]

The Declaration is retroactively effective as of February 4, 2020 and expires on October 1, 2024.[8] Manufacturers are protected from legal liability for additional 12 months from the above expiration date.[9]

For more details about the Declaration, please contact Gunjan Talati (GTalati@kilpatricktownsend.com) or Matthew Chung (Matthew.Chung@kilpatricktownsend.com).

Footnotes

Citations:
[1 Summary, https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx

[2] Id. at Supplementary Information. 

[3] Id. at Section V. 

[4] Id. at Section VI. 

[5] https://www.phe.gov/Preparedness/legal/prepact/Pages/prepqa.aspx

[6] N95 Respirators in Industrial and Health Care Settings, https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks

[7] Supplementary Information, https://www.phe.gov/Preparedness/legal/prepact/Pages/COVID19.aspx

[8] Id. at Section XII. 

[9] Id. at Section XIII. 

 

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