Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
The surge in health and wellness devices—including wearables, beauty devices and more—comes a result of consumer interest in preventive health measures. These products offer a range of benefits, from improving skin and...more
On June 3, 2025, Judge Jacqueline S. Corley of the Northern District of California granted in part a motion to dismiss a putative securities class action brought against a medical devices company (the “Company”), its CEO, and...more
Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...more
The evidentiary burden on plaintiffs to have a case certified—i.e., the “some basis in fact” standard—has been described as a “low bar” in countless cases. Plaintiffs cite the “low bar” in trying to certify their cases, and...more
Unsafe product recalls are alarmingly common. While all companies have a legal obligation to ensure that their products are safe for use or consumption, companies fail to meet this obligation far too often. In many cases,...more
Welcome to our ninth annual report on US securities class actions filed against publicly traded life sciences companies, which include pharmaceutical, biotechnology, medical device, and healthcare companies....more
A March 2024 study published by The BMJ revealed that women who were injected with Depo-Provera (medroxyprogesterone acetate) are more than five times more likely to be diagnosed with a type of brain tumor known as...more
If you are entitled to just compensation for injuries caused by a defective medical device or another dangerous or defective product, you may be able to join an existing mass tort case. This is not the same as joining a class...more
From medical devices to OTC drugs, preemption to expert preclusion, New York state and federal courts issued decisions in 2024 which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
In Bosco v Mentor Worldwide LLC, 2024 BCSC 1931, the plaintiffs alleged that Mentor's silicone gel-filled breast implants, MemoryGel, caused adverse health effects, including connective tissue disorders (CTDs) and autoimmune...more
Foley Hoag LLP publishes this quarterly Update primarily concerning developments in product liability and related law from federal and state courts applicable to Massachusetts, but also featuring selected developments for New...more
On September 10, the Food and Drug Administration (FDA) Biocompatibility and Toxicology Program published a statement announcing its intention to commission an independent literature review and internal bench laboratory study...more
Morrison Foerster Investigations + White Collar Defense partner Nate Mendell, former Acting U.S. Attorney for the District of Massachusetts, hosted the fourth episode of When Your Life Sciences Are on the Line, where leading...more
As we previously discussed, on November 7, 2023, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listings of device patents in the Food and Drug...more
Exactech has issued multiple recalls for its implantable joint replacement devices over the past few years. While Exactech has largely issued these recalls voluntarily, it has done so at the request—and with the oversight—of...more
In response to scrutiny from the U.S. Food and Drug Administration (FDA), Exactech has recalled hundreds of thousands of defective medical implant devices sold between 2004 and 2021. Despite these recalls—which began in...more
Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more
Over the past couple of decades, hundreds of thousands of patients in the United States have received defective medical implants manufactured by Exactech. While the U.S. Food and Drug Administration (FDA) has identified...more
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
Exactech has recalled hundreds of thousands of implantable ankle, knee, hip and shoulder replacement devices over the past few years. If you or a loved one received an Exactech implant in 2004 or later, it will be important...more
From pharmaceuticals to cosmetics, preemption to expert preclusion, New York state and federal courts issued decisions in 2023, which further shaped the landscape in the medical and life sciences legal world. To prepare the...more
A popular New Year’s trend is to say “goodbye” to all the things that didn’t serve you in 2023, as you usher in new intentions and habits for 2024. Although there were many great trial outcomes and continuing scientific wins...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
Medtronic Minimed, Inc. and Minimed Distribution Corp. (“Medtronic”) were sued in a class action complaint in the Central District of California on August 30, 2023, by users of Medtronic’s InPen® system. The lawsuit alleges...more
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more