Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
12/9/2022
/ 510(k) RTA ,
Classification ,
Food and Drug Administration (FDA) ,
Healthcare ,
Medical Devices ,
Medtronic ,
Regulatory Standards ,
Risk Assessment ,
Risk Management ,
SCOTUS ,
Standards & Procedures
In the game of “20 Questions,” one player secretly chooses an object and the other players are allowed 20 questions to identify it. In that spirit, answering the following 20 questions may identify a defense strategy that...more
A federal panel just granted a motion to send multiple medical device liability cases against your company to a single federal judge in a multidistrict litigation, or “MDL,” proceeding for “disposition.” Your lawyer made...more
Over the last several decades, appellate practice has transitioned from a part of general legal practice into its own discrete specialty. Luther T. Munford, an attorney in Butler Snow LLP’s appellate and written advocacy...more
In litigation-funding arrangements, an investor advances money to a party—usually a plaintiff—to pay lawsuit expenses. In exchange, the borrower agrees to give the investor a portion of his proceeds from the litigation....more
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
In this issue of Pro Te (Volume 11, No.2), we examine three important topics with practical implications.
In many jurisdictions, the medical judgment of physicians is almost sacrosanct – at least insofar as it is...more
9/21/2018
/ 21st Century Cures Act ,
Dismissal With Prejudice ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Medical Devices ,
New Guidance ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Statute of Limitations
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
We recently received this email message from Mr. Munford:
This is a letter I wish I had gotten when I started law school. I have sent it in various versions to several young friends as they began that adventure. It...more
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