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 this special collaborative episode of Ropes & Gray's Non-binding Guidance and Talkin’ Trade podcast series, life sciences regulatory and compliance partner Josh Oyster is joined by intellectual property litigation partner...more
In this episode, hosts Amy Mudge and Daniel Kaufman discuss various health-related cases involving medical devices and FTC rulings. They delve into notable cases such as the QRay bracelet, which claimed pain relief through...more
In a 5-4 ruling this month, the U.S. Supreme Court’s decision in Medical Marijuana, Inc. v. Horn significantly expanded a plaintiff’s ability to sue under the Racketeer Influence and Corrupt Organizations Act (RICO) for...more
Resolving a deep split among federal circuit courts, the U.S. Supreme Court has broadened plaintiffs’ ability to sue under the Racketeer Influenced and Corrupt Organizations Act (RICO) for economic loss stemming from personal...more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
On July 8, 2024, the U.S. Food and Drug Administration (“FDA”) issued a new draft guidance for industry titled, Addressing Misinformation About Medical Devices and Prescription Drugs – Questions and Answers (hereafter,...more
In 2022, the U.S. Food and Drug Administration (FDA or the Agency) issued a total of nine enforcement letters targeting advertising and promotion violations for prescription drugs and devices. A summary of the noteworthy...more
MASSACHUSETTS - Massachusetts Supreme Judicial Court Holds State Law Claims Against Manufacturer Of FDA-Approved Medical Device “Parallel” Federal Law Requirements And Hence Are Not Preempted Despite Failure To Identify...more
2022 AG Elections- Former South Dakota Attorney General Steps Back into Contention for AG’s Office- •Marty Jackley, who formerly served as U.S. Attorney for South Dakota, South Dakota AG, and President of the National...more
In its recent decision granting a preliminary injunction in GlaxoSmithKline v. Boehringer Ingelheim Pharmaceuticals, No. 19-5321, the United States District Court for the Eastern District of Pennsylvania enjoined a...more
Health Canada has instituted numerous measures to help address and combat COVID-19, from facilitating access to COVID-19 products to protecting the public from false or misleading advertisements claiming to prevent, treat or...more
FTC (Not) Blinded by the Light - In a first, Commission goes after low-level light therapy device makers - Chic-Light -The Willow Curve is an attractive device with all the hallmarks of contemporary design. ...more
“Treats Chronic Pain… Clinically Proven… Smart Device… Approved by the FDA…” These are all claims the Federal Trade Commission (FTC) says defendants made advertising the Willow Curve, a low-level light therapy device (LLLT),...more
COVID-19 has resulted in the launch of numerous new products, as well as numerous new claims about existing products. Products can be classified as drugs (including natural health products and hard surface disinfectants) or...more
The Food & Drug Administration is perhaps the most important, ubiquitous agency in the daily lives of modern American consumers. Consumers rely on the FDA to verify the safety and effectiveness of $2.6 trillion in food,...more
Our national response to the COVID-19 pandemic has been made more difficult by a shortage of personal protective equipment and lifesaving drugs and medical devices. Some evidence suggests that manufacturers’ fear of lawsuits...more
Health care fraud continues to be a top enforcement priority for U.S. prosecutors, and nowhere is this more true than for the medical technology sector. From 2014-2019, the U.S. Department of Justice (DOJ) brought enforcement...more
In a week that’s already seen plenty of C-suite shakeups, we’ve learned that Ginni Rometty is stepping down from her role as CEO at IBM. The company’s cloud computing chief, Arvind Krishna, will take over for her, though...more
On October 22, 2019, Skadden hosted our Ninth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York, which focused on U.S. enforcement issues companies face throughout the industry. The key...more
In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more
Many cities in the United States utilize a self-pay portal for residents to pay bills online, known as Click2Gov. Click2Gov was compromised in 2017 and 2018, when hackers were able to access over 300,000 payment cards and...more
The Situation: On January 31, 2018, the Italian Supreme Court ruled on the first Italian product-related class action promoted by a consumers' association. The Result: The Court upheld the consumer's class action claim...more
The market for apps designed to improve health and wellness or even to diagnose and treat medical conditions continues to grow. Last week, the U.S. Food and Drug Administration (“FDA”) approved a new smartphone-based “carbon...more
Last week, Apple announced the new Apple Watch Series 3 which will feature an enhanced heart rate app. The app will notify you when it detects an elevated heart rate even when you are not working out. The sensor will also be...more