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
New York’s Appellate Division, Second Department reversed a trial court order precluding defendants’ expert engineer from testifying, issuing a new trial on the issue of liability in a personal injury action stemming from a...more
New York’s intermediate appellate court, the Appellate Division, First Department, recently unanimously affirmed a Bronx County trial court decision that, when opposing parties’ experts offer conflicting affidavits, summary...more
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
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
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
New York’s Appellate Division, Second Department faced a novel question regarding interpreter bias at depositions. Zhiwen Yang v Harmon, (2023 NY Slip Op 00893 [2d Dept 2023]) stemmed from a Queens County Supreme Court...more
New York’s Appellate Division, First Department recently issued favorable dismissals to a sporting goods retailer and manufacturer in a case alleging issues with an elastic exercise band that injured a person’s right eye in a...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
The Second Department of the New York State Supreme Court Appellate Division issued two decisions in Phelps-Vachier v. Genovese Drug Stores, Inc. and Milazzo v. Best Mkt. on claims of spoliation of evidence.
Both Phelps...more
New York’s Appellate Division, Second Department reversed a trial court decision that granted a defendant’s motion to compel acceptance of a late answer. The facts on appeal entailed plaintiff completing service on November...more
The Committee on Rules of Practice and Procedure unanimously approved several amendments on June 7, 2022, to clarify Federal Rule of Evidence 702—the federal standard for admissibility of expert testimony. See Daubert v....more
New York’s Appellate Division, First Department affirmed a decision of the Bronx County Supreme Court, which precluded plaintiff’s expert evidence submitted in opposition to a summary judgment motion and following a Frye...more
When defending litigation in one state, mass tort defendants must consider other jurisdictions’ rules. For example, while some states generally prohibit a plaintiff from using a defendant’s discovery deposition as part of...more
At the beginning of 2022, New York state enacted the Comprehensive Insurance Disclosure Act (“CIDA”), imposing significant new burdens on defendants in civil ligation. We outlined the original provisions of the law in an...more
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
A California appeals court permitted a Los Angeles County wrongful death lawsuit for COVID-19 “take-home” liability to proceed. The plaintiff claims that plaintiff’s employer’s negligence resulted in plaintiff’s transmitting...more
The New York State Comprehensive Insurance Disclosure Act is now in effect. The Act amends CPLR 3101(f), governing disclosure of insurance policy information by defendants and similarly situated parties such as third-party...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
We previously wrote about a federal magistrate judge’s report and recommendation denying exclusion of Plaintiffs’ specific causation expert and granting Defendants’ motions for summary judgment in a toxic tort suit arising...more
The doctrine of collateral estoppel precludes a party from re-litigating an issue raised and decided against that party or a party in privity in a prior action. Determinations of quasi-judicial agencies, such as the Workers’...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