In the simplest case for federal preemption, federal law prohibits conduct that a state tort duty would require, such as a change in the design of an approved medical device to cure an alleged defect. Because federal law is...more
6/21/2019
/ Biosimilars ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Labeling ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
PLIVA v Mensing ,
Preemption ,
SCOTUS
Pro Te: Solutio returns for its second edition of 2019. As the year grinds on, our attorneys at Butler Snow are taking proactive and creative steps to confront and solve the issues that affect our areas of practice.
The...more
6/19/2019
/ Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Labeling ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Preemption ,
Prescription Drugs ,
Product Defects ,
Product Labels ,
Public Health ,
Supremacy Clause
It’s hard to believe a decade has passed since we delivered our first edition of Pro Te: Solutio to your door. Those years have brought enormous changes in the world and in our industry. Innovation has driven everything we...more
7/17/2018
/ 21st Century Cures Act ,
Affordable Care Act ,
Client Services ,
Depositions ,
DQSA ,
Emergency Response ,
Enforcement Actions ,
FDASIA ,
Food and Drug Administration (FDA) ,
Food and Drug Administration Amendments Act (FDAAA) ,
Health Care Providers ,
Health Insurance ,
Hospitals ,
Innovation ,
Juror ,
Jury Trial ,
Law Firm Associates ,
Law Firm Ownership ,
Law Firm Partners ,
Law Practice Management ,
Manufacturers ,
Medical Device User Fee Program (MDUFA IV) ,
Medical Devices ,
Multidistrict Litigation ,
Patient Rights ,
Patient Safety ,
Patients ,
Pharmaceutical Industry ,
Preemption ,
Questionnaires ,
Reporting Requirements ,
State Law Tort Claims ,
Voir Dire ,
Witness Preparation
Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations.
Generic preemption remains a hot topic. In Storm...more
10/10/2015
/ 510(k) RTA ,
Device Classification ,
Drug Safety ,
Failure To Warn ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Medical Devices ,
Pharmaceutical Industry ,
Preemption ,
Product Labels ,
Transvaginal Mesh