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 U.S. Court of Appeals for the Seventh Circuit recently rejected an effort by the federal government to extend the federal Anti-Kickback Statute (AKS) to a marketing company in the absence of influence by the company over...more
On April 14, 2025, the United States Court of Appeals for the Seventh Circuit reversed the conviction of the owner of a durable medical equipment (“DME”) distributor, ruling that there was insufficient evidence to support a...more
On April 14, 2025, the U.S. Court of Appeals for the Seventh Circuit issued its opinion in United States v. Sorensen, No. 24-1557, reversing the criminal conviction of Mark Sorensen, the owner of SyMed Inc., a...more
On April 14, the Seventh Circuit in United States v. Sorensen issued a decision reversing a jury conviction and narrowing the scope of the Anti-Kickback Statute (AKS) as applied to marketers and advertisers....more
Seventh Circuit Reverses AKS Conviction Involving Allegations of Illegal Marketing and Advertising - On April 14, the US Court of Appeals for the Seventh Circuit reversed the criminal conviction of Mark Sorensen after a...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity and developments occurring in January 2023, including several criminal and civil enforcement actions related to the federal...more
Ensuring compliance with the False Claims Act has never been more important for healthcare providers. By March 2020, we saw healthcare professionals standing at the forefront of one of the greatest health crises in a...more
Bass, Berry & Sims is pleased to announce the release of the 2019 edition of its Healthcare Fraud & Abuse Annual Review. Compiled by the firm’s Healthcare Fraud Task Force, the Review is an in-depth and comprehensive analysis...more
Just to repeat myself – pharmaceutical and medical device firms face extraordinary risks of enforcement under the False Claims Act. While everyone likes to write and focus on FCPA or anti-corruption risks for global drug and...more
Medical Device Exec Sentenced to 42 Months in Prison for $4.6 Million Kickback Scheme, Co-Conspirator Awaits Sentencing - On August 29, the Department of Justice announced that a Tennessee health care executive, Brenda...more
On March 15, 2018, Skadden hosted its Eighth Annual Pharmaceutical, Biotechnology and Medical Device Seminar in Palo Alto, California, which focused on U.S. enforcement issues faced by companies throughout the industry. The...more
On March 1, 2016, the United States Department of Justice (DOJ) announced that Olympus Corp. of the Americas (OCA), the nation’s largest distributor of endoscopes and related equipment, had agreed to pay $623.2 million to...more
For years, the U.S. Food and Drug Administration (FDA) has taken the position that a medical device (or drug) manufacturer that promotes an FDA-approved device (or drug) for an unapproved use violates the Federal Food, Drug,...more
On November 17, 2015, a group of Skadden attorneys and corporate counsel joined representatives from more than 20 life sciences companies to discuss U.S. enforcement issues companies throughout the industry face. The key...more