Civil immunity for Covered Countermeasures in fight against COVID-19
COVID-19 has thrust us into a global crisis unprecedented in the century since the Spanish Flu epidemic of 1918-19. It is not merely disruptive in our daily routines. It involves life, death and enormous hardship in massive scale, probably for a prolonged time. In this new reality, some of the routines dealing with individual injury cases may be eclipsed by a near term future we did not anticipate just a few weeks ago.
The “new normal” after the end of this pandemic is impossible to discern. Some pundits have emphasized hope that after the entire population passes this crucible of shared hardship and existential threat, we might emerge a kinder, more empathetic, more cooperative and public spirited nation, less torn by toxic partisanship. This will be the central formative experience for the generation forced home from school. Despite some examples of irresponsible spring break conduct, some guess that this may lead to a “Greatest Generation 2.0” in response to shared crisis. Others fearfully predict a dystopian future reminiscent of a Mad Max movie. Reality may be somewhere between those two visions.
One thing is certain. As with every cataclysmic event, legal controversies will flow from this crisis.
Already there is a declaration from the Secretary of Health and Human Services providing immunity from liability for certain individuals and entities against covered claims of loss relating to the manufacture, distribution, administration, or use of medical countermeasures (“Covered Countermeasures”), except for claims involving “willful misconduct.” This was done under the authority of the Public Readiness and Emergency Preparedness Act of 2005 (“PREP Act”), codified at 42 U.S.C. §247d-6d, and is retroactively effective beginning February 4, 2020. Tthere precedent supporting this immunity. See, e.g., Parker v. St. Lawrence County Pub. Health Dept., 102 A.D.3d 140 (3rd Dep’t 2012) (finding federal preemption over Plaintiff’s state law claim based on the unconsented vaccination of a minor during the H1N1 epidemic).
This immunity from liability applies to manufacturers, distributors, program managers, “qualified persons” (any person authorized to prescribe, administer, deliver, distribute or dispense the Covered Countermeasures), and their officials, agents, and employees authorized to prescribe, administer, deliver, distribute or dispense any antiviral, drug, biologic, or vaccine used to treat, diagnose, cure, prevent, or mitigate COVID-19, the transmission of SARS-CoV-2, or a virus mutating therefrom, or “any device used in the administration of any such product, and all components and constituent materials of any such product.”
Activities covered by this immunity from liability include manufacturing, testing, development, distribution, administration, and use of the Covered Countermeasures.
The COVID-19 Declaration is effective as of February 4, 2020 through October 2024, unless extended.
The purpose of the COVID-19 Declaration is to permit the special use of drugs and other medical products during the COVID-19 pandemic that either have not yet been approved/cleared by the FDA or may be used off-label without the risk of liability in the event of a covered injury or loss. Under the PREP Act, if there are injuries as a result of Covered Countermeasures relating to a public health emergency, the relief available can be found via the Countermeasures Injury Compensation Program (“CICP”), which is charged with establishing a fund for such injuries.
“Covered Countermeasures” include anything used against the pandemic or against adverse events from these products, including antivirals, drugs, biologics, diagnostics, devices, vaccines used to treat, diagnose, cure, prevent, or mitigate COVID-19, or the transmission of SARS-CoV-2 or a virus mutating therefrom, or any device used in the administration of any such product, and all components and constituent materials. These must be a qualified pandemic or epidemic product authorized for investigation or emergency use as defined in the PREP Act, the Food and Drug Cosmetic Act (“FDCA”), and the Public Health Service Act (“PHSA”).
The scope of immunity is not all-encompassing or absolute. Key limitations/qualifications on immunity protection are:
- Some form of premarket approval is required. The Covered Countermeasure must be approved or cleared by the FDA under the FDCA; licensed under the PHSA; or authorized for emergency use by the FDA under applicable provisions of the FDCA.
- Must be qualified pandemic or epidemic products, security countermeasures, or drugs, biologics, or devices authorized for emergency or investigational use.
- Only for “recommended activities” involving Covered Countermeasures related to present or future federal contracts or other federal transactions or agreements, or activities authorized by authorities with jurisdiction to prescribe, administer, deliver, distribute, or dispense Covered Countermeasures following an emergency declaration.
- Does not apply to death or serious physical injury caused by willful misconduct.
- Not available for foreign claims.
- Claim must arise from conduct that is directly related to the development/distribution of a Covered Countermeasure.
We may reasonably anticipate that bad things will happen, and sneaky people will claim immunity to which they are not legitimately entitled. Those issues will be fought out in court.
Mr. Shigley is the first Georgia lawyer to earn three national board certifications in his practice area from the National Board of Trial Advocacy – in Civil Trial Law, Civil Practice Law and Truck Accident Law. He is a board member of the Academy of Truck Accident Attorneys, and former chair of the American Association for Justice Motor Vehicle Collision, Highway & Premises Liability Section, which includes the Trucking Litigation Group.
He is lead author of Georgia Law of Torts: Trial Preparation and Practice, now in its tenth annual edition with Thomson Reuters West. His law practice is focused on catastrophic injury and wrongful death including those arising from commercial trucking accidents and those involving brain, neck, back, spinal cord, amputation and burn injuries.
In 2011-12, Mr. Shigley was president of the State Bar of Georgia, which includes all the lawyers and judges in Georgia. He also is a former chair of the Institute for Legal Education in Georgia (board member 2008-2020, chair 2012-13), State Bar of Georgia Tort & Insurance Practice Section (1994-95), and the Georgia Insurance Law Institute (1994).
A former prosecutor and former insurance defense lawyer, Mr. Shigley is a graduate of Furman University and Emory University Law School. He is a widower, father of two adult children, and an elder in his church.
Recently he moved his law practice to the Atlanta law firm of Johnson & Ward. He may be contacted at 404-253-7862.