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 US Department of Justice’s settlement with Illumina, Inc. is a first-of-its-kind involving alleged cybersecurity deficiencies causing violations of the False Claims Act (FCA) based on FDA quality standards. The...more
On July 31, the U.S. Department of Justice (DOJ) announced a settlement in United States ex rel. Lenore v. Illumina, Inc, the first case in which underlying cybersecurity issues formed the basis of a settlement under the...more
On July 30, 2025, the U.S. Department of Justice (DOJ) announced that biotechnology company Illumina Inc. agreed to pay $9.8 million plus interest to resolve allegations of misrepresenting compliance with federal...more
On July 2, 2025, the U.S. Department of Justice (DOJ) and U.S. Department of Health and Human Services (HHS) announced the reestablishment of the DOJ-HHS False Claims Act Working Group. Originally formed in December 2020 at...more
On July 2, 2025, the Departments of Justice and Health & Human Services announced a joint working group aimed at “strengthening their ongoing collaboration to advance priority enforcement areas” under the False Claims Act...more
Despite much recent attention to the new administration's plans to deploy the False Claim Act (FCA) to advance other policy objectives, a July 2, 2025 Department of Justice (DOJ) press release announcing a DOJ-HHS False...more
On July 2, 2025, the U.S. Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced the formation of the DOJ-HHS False Claims Act Working Group, signaling a continued and coordinated...more
On May 12, 2025, the Head of the US Department of Justice’s Criminal Division, Matthew R. Galeotti (“Galeotti”), announced DOJ’s first ever White-Collar Enforcement Plan (the “Plan”), which directs prosecutors to: (1) focus...more
Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...more
Three recent settlements demonstrate the U.S. Department of Justice’s (DOJ’s) continued scrutiny of product quality and manufacturing issues in the medical device industry. Using the civil False Claims Act (FCA) and the...more
St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities. St. Jude was acquired by Abbott Laboratories in early 2017....more
The U.S. Department of Justice (DOJ) recovered more than $2.2 billion in settlements and judgments from civil cases under the False Claims Act (FCA) in the fiscal year ending September 30, 2020. This is a drop of more than...more
A medical device manufacturer learned what might seem an obvious lesson when it paid $18 million to settle a False Claims Act lawsuit brought by its former Compliance Officer: don’t ignore your compliance officer. The federal...more
$3 billion recovered under the False Claims Act (“FCA”). That’s what the US Department of Justice (“DOJ”) reported collecting in FY2019. The health care and life sciences industries accounted for $2.6 billion of the total...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
On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more
ANTICORRUPTION DEVELOPMENTS - DOJ Files Superseding Indictment in Haitian Port Corruption Plot - On October 30, 2018, the U.S. Department of Justice (DOJ) filed a superseding indictment in the District of Massachusetts...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