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
As noted in two prior posts, one on May 15, 2020, and the other on May 29, 2020, the COVID-19 pandemic and the resulting explosion in the use of remote depositions present a number of novel issues for lawyers to consider,...more
12/21/2020
/ Attorney's Fees ,
Coronavirus/COVID-19 ,
Law Firm Associates ,
Law Firm Partners ,
Legal Coaching ,
Legal Technology ,
Remote Depositions ,
Remote Working ,
Trial Preparation ,
Virtual Litigation ,
Witnesses
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
Upon creation of multidistrict litigation involving a drug or medical device, companies may contemplate the dreaded “S-Word” —“settlement.” While an early settlement program can sometimes serve as in-house counsel’s best...more
On May 1, 2015, Alabama Governor Robert Bentley signed SB80, which expressly bars liability claims against manufacturers that did not design or make the product that a plaintiff actually ingested or used. While at first...more
Is "a short and plain statement" of the grounds for removal sufficient to remove a case to federal court? Or must a defendant supply admissible evidence in its notice of removal to prove amount in controversy? The Supreme...more
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