Is the decision to submit a 510(k) application versus a Premarket Application (PMA) at the sole discretion of a medical device manufacturer? The answer is not always clear to product liability lawyers, judges, and juries. FDA...more
By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering...more
11/24/2021
/ Consumer Fraud ,
Coronavirus/COVID-19 ,
Electronic Communications ,
Failure To Warn ,
Food and Drug Administration (FDA) ,
Manufacturers ,
Medical Devices ,
Medical Supplies ,
Over The Counter Drugs (OTC) ,
Prescription Drugs ,
Product Safety Labels ,
QR Codes ,
Regulatory Standards ,
Vaccinations
Medical supply shortages have been in the limelight since COVID-19 barreled into the U.S. and many manufacturers have been doing all they can to answer the call for more supplies. In response to this issue and recently passed...more
The U.S. Supreme Court issued its potentially most significant preemption decision in several years, Merck Sharp & Dohme Corp. v. Albright, 587 U.S. ____ (2019), reversing what some had dubbed the worst drug and device...more
5/22/2019
/ 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
Last week the U.S. Food and Drug Administration (FDA) issued two long-awaited draft guidances on social media: Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and...more