December 15, 2020

[Note Horvitz & Levy Appellate Fellow Sarah Hamill prepared this summary of products liability issues related to COVID-19.]

With the mass production of COVID-19-related products (face masks, hand sanitizer, ventilators, respirators, etc.), there has been a substantial increase in product liability cases. Potential claims include failure of protective equipment to work as promised, exposure to COVID-19 from various devices or packaging, and failure to warn about potential side effects of drugs or other medical devices.[1] Vaccine manufacturers are looking ahead to determine the liability risk they face in placing a vaccine on the market.

There may also be claims of defective COVID-19 tests.[2] Manufacturers may face claims for false positive tests, false negative tests, or dangers from the test itself.[3] A claim concerning a false positive test might assert damages for “unnecessary or detrimental care to treat an illness the patient did not have,” while a claim involving a false negative test might assert damages for “the harm caused by the failure to treat the patient for the disease and associated harms.”[4] A claim alleging harm from a COVID-19 test might also include damages for a contaminated swab.[5]

There are existing immunities for manufacturers, distributors, and administers of COVID-19-related products. The Public Readiness and Emergency Preparedness Act (PREP Act), enacted in 2005, “authorizes the Secretary of Health and Human Services (the Secretary) to issue a Declaration to provide liability immunity to certain individuals and entities (Covered Persons) against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures (Covered Countermeasures), except for claims involving ‘willful misconduct.’”[6] The Secretary published a PREP Act declaration on March 17, 2020, with a retroactive effective date of February 4, 2020.[7] Those given immunity under the PREP Act include manufacturers, distributors, program planners, and other qualified persons and their officials.[8] Covered Countermeasures include “any antiviral, any other drug, any biologic, any diagnostic, any other device, or any vaccine, 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.”[9]

Most producers of products intended to counteract the pandemic that are cleared by the Food & Drug Administration (FDA) or authorized under an Emergency Use Authorization are covered by the PREP Act declaration.[10] However, PREP Act immunity is not absolute and each case will be determined on a case-by-case basis.[11]

Because of the limitations to immunity under the PREP Act,[12] manufacturers and distributors are also turning to state law to determine whether Good Samaritan laws might offer additional protection.[13]

We will continue to monitor developments in this area, especially as companies release COVID-19 vaccines.

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[1] Joseph M. Price et al, What Product Liability Claims Can We Expect to See as a Result of COVID-19?, The National Law Review (June 25, 2020), https://www.lexisnexis.com/community/lexis-legal-advantage/b/trends/posts/product-liability-a-growing-practice-area-amidst-the-covid-19-pandemic.
[2] Jordan Lipp, Liability Risks and Litigation Defenses for COVID-19 Tests: Potential Claims and Defenses, MedTech Intelligence (Aug. 19, 2020), https://www.medtechintelligence.com/column/liability-risks-and-litigation-defenses-for-covid-19-tests-potential-claims-and-defenses/.
[3] Id.
[4] Id.
[5] Id.
[6] Dep’t of Health & Hum. Servs. Notice No. 52: Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 Fed. Register 15,198 (Mar. 17, 2020).
[7] Id.
[8] Id.; see Lipp, supra note 2; Jasmine Dela Luna et al., Retooling in the Midst of COVID-19: Statutory Protections for Manufacturers, The National Law Review (Sept. 10, 2020), https://www.natlawreview.com/article/retooling-midst-covid-19-statutory-protections-manufacturers; COVID-19 Liability Immunity – What You Need to Know Now, The National Law Review (Apr. 6, 2020), https://www.natlawreview.com/article/covid-19-liability-immunity-what-you-need-to-know-now; HHS PREP Act Declaration Offers Broad-Based Tort Immunity to Those Involved in COVID-19 Fight, Faegre Drinker (Mar. 24, 2020), https://www.faegredrinker.com/en/insights/publications/2020/3/hhs-prep-act-declaration-offers-broad-based-tort-immunity-to-those-involved-in-covid-19-fight.
[9] 85 Fed. Register at 15,202.
[10] Id.; see Lipp, supra note 2; Dep’t of Health & Hum. Servs., Advisory Opinion on the Public Readiness and Emergency Preparedness Act and the March 10, 2020 Declaration under the Act (May 19, 2020), at 4, https://www.hhs.gov/sites/default/files/prep-act-advisory-opinion-hhs-ogc.pdf.
[11] Dep’t of Health & Hum. Servs., supra note 10 at 2. After the Secretary made the PREP Act declaration, President Trump further expanded liability immunity under the Coronavirus Aid, Relief and Economic Security Act to include additional types of personal protection equipment. Do State Good Samaritan Laws Offer Any Product Liability Protection?, Faegre Drinker (Apr. 21, 2020), https://www.faegredrinker.com/en/insights/publications/2020/4/do-state-good-samaritan-laws-offer-any-product-liability-protection; CARES Act Expands Liability Protections Under the PREP Act, Faegre Drinker (Apr. 14, 2020), https://www.faegredrinker.com/en/insights/publications/2020/4/cares-act-expands-liability-protections-under-the-prep-act.
[12] See Morgan Lewis, The PREP Act: Critical Liability Immunity for Critical Products, JDSUPRA (July 29, 2020), https://www.jdsupra.com/legalnews/the-prep-act-critical-liability-81158/.
[13] Do State Good Samaritan Laws Offer Any Product Liability Protection?, supra note 11 (discussing various states’ Good Samaritan laws and whether they might offer protections for companies during the pandemic).