On August 3, New York Gov. Andrew Cuomo signed legislation (New York S.B. 8335, enacted Aug. 3, 2020) that scaled back the immunity provisions enacted toward the beginning of the COVID-19 emergency for health care providers....more
8/11/2020
/ Coronavirus/COVID-19 ,
Criminal Liability ,
Criminal Prosecution ,
Executive Orders ,
Governor Cuomo ,
Gross Negligence ,
Health Care Providers ,
Healthcare Facilities ,
Healthcare Workers ,
Immunity ,
New Legislation ,
Relief Measures
Included in the CARES Act are long-awaited reforms to the FDA’s regulation of over-the-counter (OTC) medications. H.R. 748, §§ 3851-3862. The FDA has hailed the law as granting it “transformative, new authorities that will...more
Congress designed federal multidistrict litigation (“MDL”) to “promote the just and efficient conduct” of civil actions pending in different districts. By just about any measure, though, the litigation device has failed to...more
On May 20, the U.S. Supreme Court issued its latest opinion on preemption in cases involving prescription medications, Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S. May 20, 2019). ...more
5/23/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
Often lost in the cacophony of headlines surrounding rising health care costs is the promise that value-based contracting offers as a possible solution. In contrast to the traditional fee-for-service model, value-based...more
10/6/2017
/ Alternative Payment Models (APM) ,
Anti-Kickback Statute ,
Big Data ,
Centers for Medicare & Medicaid Services (CMS) ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Medicaid ,
Medical Devices ,
Off-Label Promotion ,
OIG ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Standards ,
Value-Based Payments
The U.S. Court of Appeals for the Ninth Circuit recently upheld certification of a class of retail purchasers of Wesson-brand cooking oil in a false advertising case, despite the fact that almost all class members will never...more
4/24/2017
/ Ascertainable Class ,
Class Action ,
Class Certification ,
ConAgra ,
Cy Pres Funds ,
False Advertising ,
Food Supply ,
FRCP 23 ,
FRCP 23(b)(3) ,
GMO ,
Natural Products ,
Settlement