The Secretary of the Department of Health and Human Services (HHS) recently made a declaration to provide liability immunity to drug and medical device manufacturers, distributors and users relating to the implementation of countermeasures to the COVID-19 pandemic (the Declaration). The Declaration was effective February 4, 2020.

The ability to make this Declaration flows from the Public Readiness and Emergency Preparedness (PREP) Act, enacted in 2005, which authorizes the HHS Secretary to issue a declaration to provide liability immunity to “Covered Persons” against any claim of loss arising out of or relating to the manufacture, distribution or use of certain medical countermeasures arising out of a health emergency (Covered Countermeasures). The liability immunity does not apply to claims involving “willful misconduct” as defined in the PREP Act.

Definitions

“Covered Persons” afforded liability immunity include manufacturers, distributors, program managers and “qualified persons.”

“Qualified Persons” include any person authorized to prescribe, administer, deliver, distribute or dispense the “Covered Countermeasures.”

“Covered Countermeasures” include any “antiviral, any other drug, any biologic, and diagnostic or any other device, or any vaccine used to treat, diagnose, cure, present, or mitigate COVID-19” or its transmission, or “any device used in the administration of any such product, and all components and constituent materials of any such product.” The Declaration qualifies its definition by indicating that they must be “qualified pandemic or epidemic products” or “security countermeasures” or drugs, biologic products or devices authorized for investigational or emergency use as those terms are defined in the PREP Act, the Food Drug & Cosmetic Act and the Public Health Service Act.

Special Use of Qualified Products

Whether a drug, device or biologic qualifies for this immunity protection will likely depend on whether it is authorized for use in connection with the COVID-19 pandemic. The Declaration broadly defines those with “authority” in connection with the pandemic to include “the public agency or its delegate that has legal responsibility and authority for responding to an incident based on politic or geographical (e.g., city, county, tribal, state or federal boundary lines) or functional (e.g., law enforcement, public health) range or sphere of authority. As this is quite broad, it appears that even a local health department would be able to authorize the use of a particular countermeasure under this scheme.

The focus of this Declaration is to permit the special use of drugs and other medical products during this particular emergency (the COVID-19 pandemic) that either (1) have not yet been approved or cleared by the FDA or (2) may be used off-label without the risk of liability in the event of an injury or other claimed loss. Under the PREP Act, if there are injuries as a result of countermeasures relating to a public health emergency, the relief available can be found via the Countermeasures Injury Compensation Program (CICP), which is supposed to set up a fund for such injuries.

Defense of Claims

In the event of claims arising out of the manufacture, distribution or use of these countermeasures to the COVID-19 pandemic, a defendant would have several defenses to such claims, including but not limited to reliance on the immunity offered by the HHS Secretary’s Declaration, federal preemption over any state law claim made in connection with these countermeasures, and finally a jurisdictional challenge where the PREP Act has afforded claimants an opportunity to secure relief via a CICP fund.

A good example of these defenses in action can be found in the case of Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (3rd Dep’t 2012), where the New York appellate division reversed an order rejecting a federal preemption challenge regarding a claim based on the unconsented vaccination of a child in response to the H1N1 epidemic.

Conclusion

As the global COVID-19 pandemic continues to expand, researchers are racing to develop effective treatments and preventative measures. The HHS Declaration should facilitate implementation of these countermeasures. If you have questions regarding your status as a “Covered Person,” a “Qualified Person,” what constitutes a “Covered Countermeasure,” or how this Declaration may impact your business, please reach out to Daniel Tranen or a member of Wilson Elser’s Life Sciences team.