Product Liability for Fabric Mask Manufacturers During COVID-19May 8, 2020 – Article
Amidst the constantly changing landscape of the COVID-19 pandemic, various jurisdictions have started requiring people to wear face masks when they go out in public. The increased demand for non-medical face masks has caused non-traditional manufacturers to enter a new market space; thus, manufacturers should keep apprised of the extensive regulatory framework governing face coverings.
THE PREP ACT
The Public Readiness and Emergency Preparedness (PREP) Act authorizes the Secretary of the U.S. Department of Health and Human Services to issue a declaration establishing a public health emergency. After the issuance of a declaration, the PREP Act provides broad immunity to covered individuals or organizations manufacturing, distributing, or dispensing covered countermeasures, except in cases of willful misconduct.
On January 31, 2020, Secretary Azar declared COVID-19 a public health emergency. On March 10, 2020, he issued the requisite declaration under the PREP Act. The Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 (the Declaration) was intended to “provide liability immunity for activities related to medical countermeasures against COVID-19.” The Declaration was effective as of February 4, 2020. To summarize, the PREP Act provides immunity for claims against covered persons administering or using covered countermeasures following the issuance of a declaration, except in cases of willful misconduct.
WHO ARE COVERED PERSONS?
“Covered persons” is defined in the PREP Act to include manufacturers, distributors, program planners, and qualified persons. These terms are all further defined in the Act. Manufacturers and distributors are the focus of this article. A manufacturer includes contractors or subcontractors of a manufacturer, as well as a supplier or licenser of any product or component used in the design, development, or manufacturing of a covered countermeasure. A distributor is defined under the Act as a person or entity engaged in the distribution of drugs, biologics, or devices. The Act defines the word “person” to include an individual; partnership; corporation; entity; or public or private corporation, including federal, state, or local governments, agencies, or departments.
WHAT IS A COVERED COUNTERMEASURE?
The PREP Act defines a covered countermeasure as a “qualified pandemic or epidemic product;” a “security countermeasure;” or a drug, biological product or device authorized for emergency use by the Food and Drug Administration (FDA).
WHAT ABOUT FACE MASKS?
Congress amended the PREP Act on March 18, 2020, to include “personal respiratory protective devices” as covered countermeasures. In order to qualify as a covered countermeasure under the amendment, a personal respiratory device must be:
- approved by the National Institute for Occupational Safety and Health under part 84 of title 42, Code of Federal Regulations (or successor regulations);
- subject to the emergency use authorization issued by the Secretary on March 2, 2020 (or successor authorizations) permitting emergency use of personal respiratory protective devices during the COVID-19 outbreak; and
- used during the period beginning on January 27, 2020, and ending on October 1, 2024, in response to COVID-19.
This PREP Act amendment would have excluded fabric face masks from immunity. In response to CDC guidance on wearing cloth face coverings, the FDA issued an Emergency Use Authorization (EUA) letter on April 18, 2020 regarding fabric face masks.
Under the EUA, face masks, including fabric or cloth masks, are authorized when they are intended for use as source control by members of the general public, including health care professionals, in accordance with CDC recommendations. The EUA was re-issued on April 24, 2020, to clarify that face coverings are authorized for use by health care personnel in healthcare settings only as source control. “Source control” refers to the use of a mask covering the nose and mouth to prevent the transmission of respiratory secretions. These masks do not qualify as respiratory protective devices and are not intended to be used by health care providers as personal protective equipment.
The FDA’s emergency use authorization for fabric face masks is intended to help prevent the spread of COVID-19 and, therefore, grants the manufacturers of those masks protection under the PREP Act.
Labeling and Record Keeping Conditions
Importantly, the EUA is subject to some conditions. In order to be an authorized face mask, manufacturers must include a label with the mask which contains certain required information. First, the product must be labeled as a face mask and include a list of the materials which come into contact with the body. Second, the label must make clear that the mask is not intended for use as a surgical mask or as a liquid barrier. Third, the label must include a warning against wearing it in settings, such as clinics, where the risk of exposure is high. This third component is not to discourage mask usage in high-risk exposure settings but rather to encourage medical grade masks to be worn in those settings. Fourth, the label cannot provide any misleading information that might lead a consumer to believe that the mask protects against infection. Fifth, the mask cannot be labeled as a respiratory device or as being able to filter particulates. Finally, the mask cannot be labeled for use in high-risk aerosol-generating procedures.
In addition to the labeling requirements listed above, mask manufacturers must meet several other requirements. They must make the labeling available in hard copy format; alternatively, this labeling information can be made available on the company’s website. If the labeling is only available on the company website, the mask’s packaging must include instructions on how to access that labeling. Manufacturers must also provide instructions on how to launder or disinfect the masks. Additionally, the manufacturers must have a process in place to report any “adverse events” to the FDA. “Adverse events” typically include malfunctions that could cause death or serious injury. Finally, there are two specific record keeping requirements: (1) manufacturers must retain any and all records relating to the EUA letter and provide them to the FDA upon request; and (2) manufacturers must keep all records of sales, including who bought the masks and how many they bought.
Advertising and Promotional Conditions
When advertising the masks, manufacturers must follow the same rules that apply to labeling. Manufacturers cannot advertise that the masks prevent contracting COVID-19 or that the masks are a treatment for COVID-19. Manufacturers are also required to state clearly and conspicuously in all advertising that the masks have not been approved or cleared by the FDA; rather, they must say that the masks have been authorized by the FDA as a method of preventing the spread of infection. Finally, advertisements must also include language that the masks are only authorized during the COVID-19 outbreak.
Guidance from the FDA on EUAs is constantly evolving. Mask manufacturers should take all necessary precautions to comply with federal and state regulations, bearing in mind that PREP Act immunity does not apply in cases of willful misconduct. If you have any questions regarding the FDA’s EUA letter or the requirements in the letter, please contact us to help you navigate this constantly-developing legal terrain.
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 42 U.S.C. 247d-6d.
 85 Fed. Reg. 15198 (March 17, 2020).
 85 Fed. Reg. at 15199.
 Families First Coronavirus Response Act, Pub. L. No. 116-127 § 6005 (2020).
 Recommendation Regarding the Use of Cloth Face Coverings, Especially in Areas of Significant Community-Based Transmission, CDC (https://www.cdc.gov/coronavirus/2019-ncov/prevent-getting-sick/cloth-face-cover.html)
 Letter to Manufacturers of Face Masks, et al., FDA (April 24, 2020) https://www.fda.gov/media/137121/download
 Id. at 2.
 Id. at 3-5.
 Id. at 5-6.
 Id. at 6-7.