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
With the first half of 2025 in the rearview mirror, the government’s continued focus on False Claims Act (FCA) enforcement shows no signs of slowing. In fact, the Department of Justice recently announced the results of a...more
The U.S. Department of Health and Human Services (HHS) and U.S. Department of Justice (DOJ) on July 2, 2025, announced their intent to strengthen the DOJ-HHS False Claims Act Working Group. The announcement emphasized...more
The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more
The Department of Justice and the Department of Health and Human Services announced the reinvigoration of a False Claims Act (“FCA”) Working Group, a joint effort between the two agencies. ...more
The U.S. Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced on July 2 their formation of a False Claims Act Working Group. The announcement and the formation of the Working Group...more
On July 2, 2025, the U.S. Department of Justice (DOJ) announced the formation of a new working group in collaboration with the U.S. Department of Health and Human Services (HHS) focused on the enforcement of the False Claims...more
On July 2, 2025, the Department of Health and Human Services (HHS) and the Department of Justice (DOJ) announced the reinvigoration of their False Claims Act (FCA) enforcement efforts through the formation of a joint FCA...more
On July 2, 2025, the Department of Justice (“DOJ”) and the Department of Health and Human Services (“HHS”) announced a joint DOJ-HHS False Claims Act Working Group (the “Working Group”) that will focus on enhanced enforcement...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
In a joint announcement, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) unveiled the formation of the new DOJ-HHS False Claims Act Working Group (Working Group) – a strategic...more
On Wednesday, July 2, 2025, the U.S. Department of Justice (DOJ) and the U.S. Department of Health and Human Services (HHS) announced the creation of a DOJ-HHS False Claims Act Working Group. The Working Group is a procedural...more
Now in its sixth month, the second Trump administration has made clear that the False Claims Act (FCA) will remain a central tool in its efforts to combat fraud, waste, and abuse across federal programs....more
On July 2, 2025, the Department of Justice (DOJ) and the Department of Health and Human Services (HHS) announced the creation of the DOJ-HHS False Claims Act Working Group, a high-level interagency initiative aimed at...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
Last week, the US Court of Appeals for the Fourth Circuit in United States v. Jackson upheld a doctor’s conviction under Section 301(k) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 USC § 331(k) (Section 301(k)), for...more
Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more
The HHS Office of Inspector General issues a favorable advisory opinion regarding a sponsor’s payment of cost-sharing amounts in a Medicare Category B IDE Clinical Study; the FDA issues guidance regarding the use of Digital...more
Federal Judge Affirms $487 Million Judgment Against Medical Device Distributor for FCA Violations - On May 12, 2023, US District Judge Wilhelmina M. Wright of the District of Minnesota affirmed the entry of a $487 million...more
A laboratory company based in Texas, Genotox Laboratories Ltd., recently reached an agreement with the federal government to resolve False Claims Act and Anti-Kickback Statute violations, stemming from allegations related to...more
After a rare False Claims Act (FCA) trial—especially one premised on violations of the Anti-Kickback Statute (AKS)—a federal jury in Minnesota returned a $43 million verdict against Precision Lens, a distributor of medical...more
On January 4, 2023, the Department of Justice issued a press release stating that Jet Medical Inc. has agreed to pay $200,000 to resolve criminal allegations relating to a migraine headache treatment. Jet Medical and two...more
The Department of Justice (“DOJ”) recently announced two settlement agreements, both involving durable medical equipment (“DME”) companies, following allegations that the companies had violated the Anti-Kickback...more
STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more
The Department of Justice announced in a February 1, 2022 press release (Press Release) that it obtained more than $5.6 billion in settlements and judgments from civil cases involving fraud and false claims in the fiscal year...more
DOJ Files Complaint in AWP False Claims Act Suit Against Pharmaceutical Ingredient Seller - On November 8, 2021, the Department of Justice (DOJ) announced that it intervened in a qui tam suit and filed a False Claims Act...more