False Claims Act Insights - Are All Healthcare “Kickbacks” Subject to FCA Liability?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 204: Accelerating Life Sciences Startups with James Chappell of SCbio
Podcast — Drug Pricing: How Are Payers Responding to the IRA?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 203: Manufacturing Specialty Drugs for Rare Diseases in North Carolina with Paul Testa of Kyowa Kirin
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 Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 195: Life Sciences and Healthcare Workforce Development with Dr. John Hauser of Gaston College
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 194: Workforce Development for the Life Sciences Industry with David Stefanich of Rymedi
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Changes in FDA, Cannabis Policies and AI Developments
340B Drug Pricing Program Compliance
Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist
Episode 183: Site Development for Life Sciences Companies with Adam Bruns of Site Selection Magazine
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 171: Laura Gunter, President of the NC Life Sciences Organization
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 165: Doug Edgeton, President and CEO of the North Carolina Biotechnology Center
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 163: David Ellison, Chief Data Scientist for Lenovo’s Infrastructure Solutions Group
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
On June 27, 2024, the United States Supreme Court decided the Purdue Pharma appeal. In a five-to-four decision, the Supreme Court held that a bankruptcy court may not extend to non-debtors the benefits of a Chapter 11...more
The Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more
Multistate groups of AGs reached two settlements related to claims involving the U.S. opioid epidemic. Publicis Health, LLC settled with a coalition consisting of all AGs from every state, territory, and the District of...more
David Conaway reports on a recent Chapter 11 plan of reorganization submitted by Purdue Pharma (Oxycontin) to resolve a mass tort claim. The Supreme Court of the United States (SCOTUS) is having difficulty swallowing the...more
There is longstanding controversy concerning the validity of third-party release provisions in non-asbestos trust chapter 11 plans that limit the potential exposure of various non-debtor parties involved in the process of...more
Non-consensual third-party releases are provisions in reorganization plans that release non-debtor parties from liability to other non-debtor parties without the consent of all potential claimholders. These releases are...more
On February 7, 2023, the U.S. Department of Justice (DOJ) announced its fiscal year (FY) 2022 False Claims Act (FCA) statistics. Utilizing DOJ’s FY 2022 Data Table and comparing back to our FY 2021 coverage, MoFo’s FCA team...more
Earlier this month, the U.S. Department of Justice (DOJ) Civil Division's Consumer Protection Branch (CPB) released its first-ever annual "recent highlights" report. The report describes the CPB's accomplishments from October...more
Two recent decisions by U.S. District Courts have rejected attempts to include nonconsensual third party releases in chapter 11 reorganization plans. These rulings suggest third party releases may be facing increasing push...more
A plutocratic clan has upped its ante by $1.5 billion in an apparently successful bet that using bankruptcy courts, mediation, and offering to settle giant claims in the opioid abuse and drug overdose crisis will be cheaper...more
Big Pharma is blazing a legal trail that wealthy corporations are racing to follow. The corporatists are using a new approach to crush patients and other consumers who seek justice in the civil system with claims that drug...more
On February 3, 2022, as part of a series of recent decisions addressing third-party releases, Bankruptcy Judge John T. Dorsey of the Bankruptcy Court for the District of Delaware (the “Bankruptcy Court”) confirmed the chapter...more
While Republicans and a handful of Democrats in Congress may be filling campaign coffers and pleasing wealthy corporations to the nth degree during the current lawmaking session, regular folks have reason to be aghast at how...more
In a landmark opioid painkiller case, a federal bankruptcy judge has approved what potentially may be a $10-billion settlement. It included a plutocratic clan winning sweeping protections from further civil lawsuits by...more
Just as attorneys generals for more than a dozen states inch toward a multibillion-dollar settlement with a drug maker faulted for its big role in the start of the opioid abuse and drug overdose crisis, that health menace is...more
While too many of us get overdosed with clownish depictions - from doctors, hospitals, insurers, and corporations, especially Big Pharma firms - of how the civil justice system operates, it’s always worth a reminder of the...more
Over the last two months, McKinsey & Company — one of the world’s largest consulting firms — resolved matters with all 56 state attorneys general regarding investigations into its role in providing marketing and consulting...more
Members of the plutocratic Sackler clan have upped the ante yet again in a bankruptcy court bid to settle thousands of lawsuits targeting Purdue Pharmaceutical, the company long in the family’s grip and blamed for untold...more
Purdue Pharma has outlined its own plan to remove Sackler family control and restructure the pharmaceutical giant on the other side of bankruptcy—a 300-page effort that amounts to the company’s “formal bid to end thousands of...more
Notable Cases - Here are a few of the major cases of interest within the state Attorneys General community that are receiving significant press coverage. ...more
2022 AG Elections- Arkansas Lt. Governor Announces Intent to Run for Attorney General- •Arkansas Republican Lieutenant Governor Tim Griffin announced that he is dropping his gubernatorial bid and is running for...more
The official transition to a new administration and early Cabinet selections helped drive Wall Street to new highs on Tuesday, with the Dow topping 30,000 for the first time and the S&P 500 up 1.6% to another new high, too....more
Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family - On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...more
The Justice Department on Wednesday announced an $8.3 billion settlement with Purdue Pharma as part of a deal in which the company will plead guilty to criminal charges “related to its marketing of the addictive painkiller”...more
Drug warning labels must comply with federal regulations and receive approval from the Food and Drug Administration (“FDA”) before going to market. Therefore, manufacturers may argue that state law actions related to the...more