Partner
The sudden rise and spread of COVID-19 demanded an unprecedented supply of personal safety gear for healthcare workers and the general public. In addition to eye shields and gloves, there arose an urgent need for fabric face masks.
Face masks provide a barrier against the airborne coronavirus and have been deemed an effective countermeasure against COVID-19. With high demand taxing existing face mask manufacturers, several New Jersey-based companies began producing fabric face masks to meet public needs.
New Jersey products liability attorneys caution consumers on the use of these fabric masks, which may not offer you the protection you think it does.
Duty of Care For Manufacturers of Face Masks Against COVID-19
General product liability rules dictate a duty of care by manufacturers to protect consumer safety. In general, products should be manufactured without defects that might pose risks during ordinary use, and they should be reasonably safe for their intended purpose. Any inherent risks to using a product must be brought to the consumer’s attention through appropriate warning labels.
FDA Duty of Care Requirements for Fabric Face Masks
Manufacturers of fabric face masks should follow the standards detailed in the FDA Letter of Authorization. The FDA Letter of Authorization establishes duty of care requirements that, when followed, significantly reduce a manufacturer’s exposure to product liability and other claims.
Authorized Face Mask Requirements
- The product is not labeled as a respiratory protective device, and therefore should not be used for particulate filtration
- The product is not labeled for use in high risk aerosol generating procedures.
- The product labeling includes recommendations against use in a clinical setting where the infection risk level through inhalation exposure is high
- The product is labeled accurately so that it does not claim to be intended for use as a surgical mask or to provide liquid barrier protection
- The product is not labeled in a manner that misrepresents the product’s intended use; i.e. the labeling must not state or imply that the product is intended for antimicrobial or antiviral protection or related uses or is for use such as infection prevention or reduction
- The product is labeled accurately to describe the product as a face mask and includes a list of the body contacting materials
The HHS Declaration of Immunity: Are Mask Manufacturers Protected?
Fabric mask manufacturers receive some protections under the HHS Declaration of Immunity. The Declaration provides liability immunity under Federal and State Law to certain entities 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”
It is important to note that the provisions of the HHS Declaration do not provide blanket immunity. Factors including willful misconduct or lack of U.S. jurisdiction may compromise the protections afforded by the HHS Declaration.
To better understand coverage under the HHS Declaration of Immunity, careful review of its provisions is recommended. Further, adherence to the FDA Face Mask requirements is essential to ensure liability protection.
If you have become ill or otherwise injured due to a face mask that does not offer the protection it was designed for, you may be have a cause of action against the mask manufacture. Contact our New Jersey product liability lawyers today if you have questions.