Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more
3/25/2025
/ Deadlines ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Manufacturers ,
Pharmaceutical Industry ,
Pharmacies ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
Supply Shortages ,
Trademarks
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
1/23/2025
/ Biologics ,
Class Action ,
Daubert Standards ,
Dietary Supplements ,
Expert Witness ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Rules of Civil Procedure ,
Food and Drug Administration (FDA) ,
Injunctive Relief ,
Life Sciences ,
Medical Devices ,
Negligence ,
Over The Counter Drugs (OTC) ,
PFAS ,
Preemption ,
Product Defects ,
Summary Judgment ,
Vaccinations
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
While the intention is never to create a product that will be recalled, it is a fairly common occurrence. And while the scope of a recall may vary greatly depending on the product and individual facts at issue, the days...more
The first quarter of 2023 witnessed significant litigation and regulatory developments that will undoubtedly affect members of the chain of commerce in the food and beverage industry. Specifically, putative class actions...more
For the first time since the passage of the Food, Drug and Cosmetic Act in 1938, the Federal cosmetics law has been substantially updated with the passage of the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”)....more
From pharmaceuticals to toothpaste, preemption to public health, New York state and federal courts issued decisions in 2022 that further shaped the landscape in the medical and life sciences legal world. To prepare the best...more
1/19/2023
/ Class Action ,
Consumer Fraud ,
Deceptively Misdescriptive ,
Failure To Warn ,
Food and Drug Administration (FDA) ,
Implied Warranties ,
Labeling ,
Life Sciences ,
Medical Devices ,
Misleading Statements ,
Negligence ,
New York ,
Pharmaceutical Industry ,
Popular ,
Putative Class Actions ,
Strict Liability ,
Unfair or Deceptive Trade Practices ,
Vaccinations
From pharmaceuticals to dietary supplements, preemption to public health, New York state and federal courts issued decisions in 2021, which further shaped the landscape in the medical and life sciences legal world. To prepare...more
1/27/2022
/ Breach of Warranty ,
Class Action ,
Consumer Fraud ,
Dietary Supplements ,
Dismissals ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
FRCP 12(b)(3) ,
Life Sciences ,
Manufacturers ,
Medical Devices ,
New York ,
Pharmaceutical Industry ,
Preemption ,
Premarket Approval Applications ,
Public Health ,
Strict Product Liability ,
World Health Organization
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
From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more
1/29/2021
/ Bayer ,
Contraceptives ,
Design Defects ,
Failure to Report ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Medical Devices ,
Merck ,
Mirena IUD ,
New York ,
Pfizer ,
Summary Judgment ,
Teva Pharmaceuticals ,
Transvaginal Mesh
In response to the COVID-19 pandemic, numerous manufacturers and distributors of products ranging from CBD, to herbal products and supplements, to ingestible silver, began to market their products as those that could...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
MemoryGel silicone breast implants are Class III medical devices, approved by the FDA through the premarket approval (PMA) process in 2006. Premarket approval was a federal requirement imposed on the device. Plaintiff sued in...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)
The Food and Drug Administration has issued a new draft breast implant guidance recommending that manufacturers strengthen labeling about the potential complications and risks of the medical devices, particularly by adding...more
The Food and Drug Administration (FDA) has announced that data reviewed on the risks associated with textured breast implants and anaplastic large cell lymphoma (BIA-ALCL) does not require a ban of this medical device under...more
The Food and Drug Administration (FDA) has issued a safety warning regarding the use of robotically assisted surgical devices for mastectomies and other cancer surgeries, asserting that "the safety and effectiveness of...more
The Food and Drug Administration (FDA) has taken the unusual step of limiting and restricting sales of the birth control medical device, Essure®, to healthcare providers who provide adequate risk versus benefit discussions...more