Product Liability & Mass Torts Digest

A recent decision from the Ninth Circuit calls into question whether the Public Readiness and Emergency (PREP) Act provides complete immunity from state law claims related to medical countermeasures against COVID-19, finding that the federal statutory scheme is not so comprehensive that it entirely supplants causes of action based on state law. Saldana v. Glenhaven Healthcare LLC, No. 20-cv-05631-FMOMAAA (9th Cir. Feb. 22, 2022).

Nursing home operators have generally been unable to remove to federal court negligence claims premised on alleged failure to take proper COVID-19 precautions.

Effective January 28, 2021, the acting secretary of the Department of Health and Human Services (HHS) amended the Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19.

On January 8, 2021, the General Counsel for the Department of Health and Human Services (HHS) issued an Advisory Opinion clarifying the scope of preemption under the Public Readiness and Emergency Act (PREP Act) in response to questions as to whether the PREP Act applies where a covered person declined to use a covered countermeasure when it arguably ought to have been used.

On December 3, 2020, the Department of Health and Human Services (HHS) issued an expansive Fourth Amendment to its original Public Readiness and Emergency Preparedness Act (PREP Act) Declaration for Medical Countermeasures Against COVID-19.

As litigation involving the Public Readiness and Emergency Preparedness Act (PREP Act) and the Department of Health and Human Services (HHS) COVID-19 Declaration grows, some courts are following the logic set forth in two cases we previously discussed—Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020) and Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074 (D. Kan. Aug. 19, 2020)—in rejecting defendants’ attempts to use the PREP Act as a basis for removal of state court actions, suggesting limitations of PREP Act immunity from state tort claims related to COVID-19.

As litigation involving the Public Readiness and Emergency Preparedness Act (PREP Act) and the Department of Health and Human Services (HHS) COVID-19 Declaration begins, two recent court decisions provide initial insights on potential limits to the scope of preemption provided by the PREP Act immunity for COVID-19 claims: Estate of Maglioli v. Andover Subacute Rehab. Ctr. I, 2020 WL 4671091 (D.N.J. Aug. 12, 2020) and Baskin v. Big Blue Healthcare, Inc., 2020 WL 4815074 (D. Kan. Aug. 19, 2020).

On August 24, 2020, the Secretary for the Department of Health and Human Services (HHS) issued a Third Amendment to the March 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for medical countermeasures against COVID-19. 

On August 19, 2020, the Department of Health and Human Services (HHS) rescinded prior guidance and “other informal issuances” concerning premarket review and authorization of laboratory developed tests “LDTs) for COVID-19 and “future pandemics.”

On June 4, 2020, the Secretary for the Department of Health and Human Services (HHS) issued a Second Amendment to the March 2020 Declaration Under the Public Readiness and Emergency Preparedness Act (PREP Act) for medical countermeasures against COVID-19.

Along with the expansive tort liability immunity offered by the recent Declaration of the Secretary of the Department of Health and Human Services (HHS), several states continue to expand immunity from liability for businesses and manufacturers during the COVID-19 pandemic.

As manufacturers and distributors of COVID-19 products respond to the pandemic, on April 14, 2020, the General Counsel for the Department of Health & Human Services (“HHS”) issued an Advisory Opinion in response to numerous requests for more clarity on the scope of immunity from tort and contract claims under the Public Readiness and Emergency Preparedness Act (“PREP Act”).

To provide guidance to pharmacists seeking to understand whether they may order and administer COVID-19 diagnostic tests under the PREP Act, even in states restricting them from doing so, the Department of Health and Human Services (HHS) issued an Advisory Opinion on May 19, 2020. The HHS concluded that the PREP Act preempts state and local requirements prohibiting a pharmacist from ordering and administering authorized COVID-19 tests.

Manufacturers and distributors of COVID-19 products (or countermeasures) necessary to combat the spread of infectious disease are understandably concerned about potential liabilities. Online advertisements are already offering legal services to pursue product liability and other claims related to COVID-19 treatments.

While various federal agencies are providing immunity to liability for manufacturers and distributors of certain COVID-19 drugs and products, some states are likewise taking significant steps to grant immunity to those involved in the fight against the pandemic.