Cyberattacks affecting internet-connected medical devices like insulin pumps, intracardiac defibrillators, mobile cardiac telemetry, pacemakers and intrathecal pain pumps have increased in recent years. And such attacks show...more
2/21/2023
/ Cyber Attacks ,
Cybersecurity ,
Data Breach ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Industry Standards ,
Food and Drug Administration (FDA) ,
Hackers ,
Hospitals ,
Innovative Technology ,
Internet of Things ,
Manufacturers ,
Medical Devices ,
Popular ,
Regulatory Agenda ,
Regulatory Standards
While we all rely on Google or other internet search engines to find and absorb information quickly these days, a recent decision in the Central District of Illinois highlights the problems for expert witnesses relying on...more
2/2/2022
/ Admissibility ,
Amended Rule 702 ,
Causation ,
Daubert Standards ,
Discovery ,
Evidence ,
Expert Testimony ,
Expert Witness ,
Lipitor ,
Popular ,
Search Engines
During the Trump administration, the number of consumer product safety recalls fell for three years in a row. When Robert Adler became Acting Chair of the U.S. Consumer Product Safety Commission (CPSC) in 2019, he compared...more
The exact dollar amount that third-party investors infuse in U.S. lawsuits every year is unknown, but conservative estimates begin around $2.3 billion, with agreement that the industry has room to grow. With the ongoing...more
The U.S. Food & Drug Administration (FDA) has released a Funding Opportunity Announcement (FOA) titled “Exploring the use of Real-World Data to Generate Real-World Evidence in Regulatory Decision-Making (U01) Clinical Trials...more