This article was originally published in DRI‘s The Voice Volume 19, Issue 29.
It’s been nearly six months since the U.S. Department of Health and Human Services (HHS) Secretary declared COVID-19 a public health emergency. As some communities begin phasing out of their respective quarantine statuses, product businesses are on high alert for the liability vulnerabilities that may surface, and the inevitable lawsuits that they will face. This article addresses various immunities and limitations on liability that may be available to product businesses in the COVID-19 era.
Tort Immunity Under the PREP Act Declaration
In March 2020, the HHS Secretary issued a declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. § 247d-6d, proclaiming legal immunity for manufacturers, suppliers, and other similar businesses regarding products used in the fight against COVID-19. Specifically, “covered persons” are immune from suit and liability under federal and state law against “all claims for loss caused by, arising out of, relating to, or resulting from the administration to or the use by an individual of a covered countermeasure” for a “recommended activity,” except in instances of willful misconduct.
Whether a business will be afforded protection under the Declaration depends on who you are, what you do, and how you do it.
- “Covered persons” are “manufacturers,” “distributors,” “program planners,” “qualified persons,” and their officials, agents, and employees, and the regulations further define those terms to expand the body of businesses protected.
- “Covered countermeasures” are antivirals, drugs, biologics, diagnostics, devices, and 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 of any such product.” But to receive protection, the countermeasure must be qualified or approved as further defined in the Declaration.
- “Recommended activities” are “the manufacture, testing, development, distribution, administration, and use of the Covered Countermeasures.”
If the Declaration applies, a business will be afforded immunity for the following: death; personal injury (physical, mental, or emotional); fear of personal injury; property damage, and “business interruption loss.” Significantly, coverage “applies without regard to the date of the occurrence, presentation, or discovery of the loss.”
In the COVID-19 era, state and federal regulators are telling businesses what to do and what not to do at unprecedented levels. As a matter of fundamental fairness, businesses operating under these “directives” should not be subject to civil liability when acting under, or in accordance with, such active government supervision or guidance. Extensive case law supports this position. See, e.g., FCC v. Fox Television Stations, Inc., 567 U.S. 239 (2012); Cipollone v. Ligett Grp. Inc., 505 U.S. 504 (1992); United States v. Pa. Indus. Chem. Corp., 411 U.S. 655 (1973); United States v. Hoechst Celanese Corp., 128 F.3d 216 (4th Cir. 1997).
The U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been at the forefront of issuing COVID-19-related guidance. While much of this guidance contains the usual bureaucratic disclaimers, such as “contains nonbinding recommendations,” compliance with it should provide a defense against civil liability, especially given the unprecedented nature of the pandemic. See, e.g., Allergan USA, Inc. v. Prescribers Choice, Inc., 364 F. Supp. 3d 1089 (C.D. Cal. 2019).
On the other hand, the decision not to follow FDA, CDC, or other regulatory guidance invites risk, notwithstanding that the guidance, standing alone, is not mandatory. See, e.g., Costa v. Bazron, 2020 WL 2410502 (D.D.C. May 11, 2020). Litigants should remain mindful of due process-based arguments for non-liability when acting in accordance with CDC directives.
States are increasingly acting to fill the void left by Congress’s failure to date to enact comprehensive COVID-19-related legislation. For example, Utah’s law affords civil immunity to any “person” (broadly defined) for claims of exposure to COVID-19 while on the person’s premises, absent willful misconduct or reckless or intentional harm. And in Oklahoma, immunity is tied to the business acting “in compliance or consistent with federal or state regulations” or other applicable guidance, such as the CDC and FDA guidance discussed above. Some states are parsing protections. For example, Louisiana’s package of laws includes an act specifically tailored to restaurants, and Mississippi’s act attempts to immunize persons who design, manufacture, sell, or otherwise distribute “a qualified product in response to COVID-19” for injury related to that product.
While these legislative efforts are positive steps for product businesses, progress is both slow and uncertain.
Businesses unable to avoid suit on the front end through legislation or other dispositive affirmative defenses may still be able to avoid a trial or an unfavorable verdict. A cognizable personal injury claim arising from COVID-19 will require proof of general causation, i.e., that COVID-19 can be transmitted and contracted in the manner alleged, and specific causation, i.e., that the plaintiff did, in fact, contract COVID-19 as pleaded. The substantial unknowns and conflicting information regarding the spread of COVID-19, including how long the virus survives on various surfaces or lingers in the air in different atmospheric conditions, and the incubation period between exposure and symptom onset, will make a plaintiff’s already substantial burden of proof that much more difficult to meet.
The uncertainty about when the COVID-19 era will end comes with the expectation that additional defense options for product businesses operating during the pandemic will emerge. In the meantime, stay informed, follow applicable guidance, and continue to urge clients to use best practices in their day-to-day operations.
Mitchell K. (Mitch) Morris practices in Butler Snow LLP’s product liability, toxic tort, environmental, and commercial litigation groups in the firm’s Richmond, Virginia, office. He regularly represents clients nationally in high-exposure traumatic injury, wrongful death, intentional tort, environmental, pharmaceutical and complex commercial matters, and he has served as national punitive damages counsel to a Fortune 250 transportation company. Mr. Morris also devotes a significant part of his practice to combatting fraud and abuse in mass and class actions. He is a member of the DRI Product Liability Committee.
Kathleen (Kat) Ingram Carrington practices in Butler Snow LLP’s product liability, toxic tort, and environmental groups in the firm’s Jackson, Mississippi, office. She specializes in personal injury and product liability litigation related to recalled products and allegations of product defect; she represents clients in a wide range of industries, including manufacturers of recreational vehicles, industrial machinery, and automobiles. Mrs. Carrington has experience serving as lead trial counsel and a key member of the trial team in several significant trials. She also maintains an active appellate practice in both state and federal courts across the United States. Mrs. Carrington is also a member of the DRI Product Liability Committee.