How Liable Are PPE Manufacturers for Their Defective Products?

PPE Manufacturer Liability for Defective Personal Protective Equipment

Given that China, ground zero for the coronavirus pandemic, manufactures 50% of the masks and respirators produced worldwide, the U.S. faced a sudden shortage in personal protective equipment in March. To face these challenges, many domestic manufacturers have taken it upon themselves to aid the health care system by providing hospitals with the necessary PPE; however, some manufacturers may be skirting the law by producing faulty equipment or making false promises that could lead to product liability issues. Before contacting a personal injury lawyer to file a suit, it is important to understand the PPE manufacturer liability immunity granted during these extreme times.

Immunity Granted from PPE Manufacturer Liability

On March 10, 2020, the Secretary of Health and Human Services issued a declaration that gave manufacturers and suppliers of drugs a layer of protection against torts.

This layer of protection was provided for by the Public Readiness and Emergency Preparedness Act, also known as the PREP Act, signed by President George W. Bush in December of 2005. The PREP Act gave vaccine manufacturers immunity against torts during times of emergencies as vaccines were considered vital “countermeasures.”

The Declaration made in early March of 2020 classified drugs, devices, and PPE as necessary “countermeasures” to combat the coronavirus. This gave their manufacturers and suppliers a shield against torts, the same shield given to vaccine manufacturers.

To better understand the Declaration, let’s look at the business it covers, the products it includes, and the activities it protects.

Covered businesses: Any entity that manufactures, tests, develops, or is in any way related to “covered countermeasures” is immune and cannot be sued under federal or state law. This means that the term “covered persons” can apply to manufacturers and distributors of PPE so long as these PPE are “covered products.”

Covered products: Any “covered product” has to classify as a “covered countermeasure,” which can include drugs and devices that are used to combat COVID-19 along with any drug or device necessary to administer or supplement them. This effectively protects a large portion of the supply chain of manufacturers, such as material suppliers to PPE manufacturers.

Covered activities: Manufacturing, testing, developing, distributing, and administering of “covered countermeasures” are all considered “covered activities.” However, there are a few limitations.

Limitations to Immunity

Immunity is only applicable to activities that pertain to federal contracts, both present and future, as well as any other federal transactions. Immunity also applies if the activity in question was sanctioned by a designated health authority that had the right to do so once an emergency had been declared.

For a product to qualify as a “covered countermeasure,” it needs to be approved or cleared as per the Food, Drug, and Cosmetic Act. Alternatively, the product can be licensed under the Public Health Service Act. The product can also receive authorization for “emergency use,” which also falls under the provisions of the Food, Drug, and Cosmetic Act.

Immunity against torts does not apply in cases where the manufacturer acted in a willfully malicious manner, resulting in serious injury or even death. However, in these cases, the plaintiff has to prove that the misconduct was intentional. Furthermore, immunity does not extend outside the United States’ jurisdiction.

Bearing this in mind, if you or someone you know has contracted the virus as a result of using defective PPE, you might want to contact a personal injury lawyer and file a suit so long as immunity does not apply. The types of product liability claims you can make may be tied to consumer fraud, marketing misrepresentation, or breach of warranty. You might also be able to make a claim based on negligence or failure to warn. The hardest claims to make will probably be strict liability claims.

To learn more, do not hesitate to contact Rebenack, Aronow & Mascolo, L.L.P. While we have New Jersey offices in New Brunswick, Somerville, and Freehold, we’re offering virtual meetings during the pandemic. Furthermore, you can reach us via email at contact@ram.law or call us at any of our locations. The number for our New Brunswick office is (732) 247-3600, the number for our Somerville office is (908) 448-2560, and the number for our Freehold office is (732) 828-2234.