From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
1/19/2024
/ Causation ,
Class Action ,
Cosmetics ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Recalls ,
Liability ,
Life Sciences ,
Medical Devices ,
Multidistrict Litigation ,
New York ,
Over The Counter Drugs (OTC) ,
PFAS ,
Popular ,
Pre-Market Notification ,
Prescription Drugs ,
Public Readiness and Emergency Preparedness Act (PREP Act) ,
Summary Judgment
With the implementation of the largest adult vaccination program in U.S. history, with over 270 million people receiving at least one shot of a COVID-19 vaccine and 15 million courses of COVID-19 treatment administered, the...more
When the estates of nursing home residents who died from COVID-19 brought negligence and wrongful death lawsuits in New Jersey state court, defendant nursing homes removed the suits to federal court under the Public Readiness...more
The Secretary of the U.S. Department of Health and Human Services (HHS) has issued the Eighth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act (“PREP Act”) for Medical Countermeasures...more
The Public Readiness and Emergency Preparedness Act (PREP Act), 42 U.S.C. 247d-6d, provides liability immunity related to the manufacture, testing, development, distribution, administration and use of medical countermeasures...more
The FDA recently reissued an Emergency Use Authorization (“EUA”) for the sale and import of certain non-NIOSH-approved respirators manufactured in China and used by healthcare personnel in the United States but, critically,...more
In response to increased concerns regarding insufficient personal protective equipment (“PPE”), the FDA recently issued an Emergency Use Authorization (“EUA”) applicable to face masks for use by both the general public and...more
4/28/2020
/ Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Distributors ,
Emergency Use Authorization (EUA) ,
Food and Drug Administration (FDA) ,
Healthcare Workers ,
Immunity ,
Manufacturers ,
Masks ,
Personal Protective Equipment ,
Public Readiness and Emergency Preparedness Act (PREP Act)
In times of national public health crises such as the COVID-19 pandemic, manufacturers and distributors of products are often called to the frontlines of battle to create, supply, and administer the tools necessary to combat...more