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Regulatory Oversight Healthcare Enforcement Actions

Kerr Russell

What Causes a LARA Investigation?

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Question: Over the years, several of my colleagues and I have been the subject of investigations by the Michigan Department of Licensing and Regulatory Affairs. In most of these cases it’s hard to imagine why LARA is...more

Dacheng

Regulatory Escalation in Pharma Sector: China Imposes First Executive Sanctions in a Cartel Case

Dacheng on

On May 9, 2025, the Tianjin Municipal Administration for Market Regulation (“Tianjin AMR”) announced administrative penalties against four manufacturers of dexamethasone sodium phosphate (“DSP”) active pharmaceutical...more

Davis Wright Tremaine LLP

Stay ADvised: 2025, Issue 6

Reckitt Benckiser Tastes Sweet Success as Mucinex Honey False Ad Dismissed - Plaintiffs alleging that Reckitt Benckiser falsely advertised certain Mucinex products as containing honey failed to sufficiently allege that the...more

Stevens & Lee

U.S. HHS Announces Closure of Six Regional Locations of the Office of the General Counsel

Stevens & Lee on

On March 11, 2025, the U.S. Department of Health and Human Services (HHS) announced plans for a “reorganization of the Office of the General Counsel” (OGC) “[a]s part of the department’s ongoing efforts to advance the...more

Arnall Golden Gregory LLP

HHS to Close 6 of 10 Regional OGC Offices, With Potentially Significant Impacts on Providers and Suppliers

On Tuesday, March 11, 2025, the U.S. Department of Health and Human Services (“HHS”) announced plans to close six of the nation’s 10 regional offices for the HHS Office of the General Counsel (“OGC”). These closures, which...more

McDermott Will & Emery

This Week in 340B: February 4 – 10, 2025

McDermott Will & Emery on

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Quarles & Brady LLP

PE in Healthcare – Recent Governmental Commentary Could Indicate Policy Changes on the Horizon and Time for Increased Vigilance

Quarles & Brady LLP on

Recent reports published by the Senate Budget Committee (the “Committee”) and the U.S. Department of Health and Human Services (“HHS”) highlight what the authors characterize as concerns related to private equity (“PE”)...more

K&L Gates LLP

Private Equity Firms Should Prepare for Increased Scrutiny as DOJ Puts False Claims Violations Under the Microscope

K&L Gates LLP on

Private equity investment in health care has grown significantly over the past two decades, and the US government is starting to pay attention. Recent announcements by the US Department of Justice (DOJ) and proposals by...more

Troutman Pepper Locke

FTC and Bipartisan State AGs Win Landmark Case Against ‘Pharma Bro’ Martin Shkreli Over Daraprim Monopoly

Troutman Pepper Locke on

On January 23, the U.S. Court of Appeals for the Second Circuit affirmed a district court ruling that Martin Shkreli, CEO of Vyera Pharmaceuticals (Vyera), violated federal and state laws by engaging in illegal and...more

Bass, Berry & Sims PLC

What Does the DOJ’s New Civil Cyber-Fraud Initiative Mean for You?

Bass, Berry & Sims PLC on

As discussed in a previous post, the Department of Justice (DOJ) has announced a new Civil Cyber-Fraud Initiative to utilize one of the strongest tools in its toolbox—the False Claims Act—to hold entities receiving federal...more

Searcy Denney Scarola Barnhart & Shipley

FDA Warns of Risk of Failure in Stryker STAR Ankle Replacement Devices

The U.S. Food and Drug Administration (FDA) is warning patients and healthcare providers of a “higher than expected risk” of failure in Stryker Scandinavian Total Ankle Replacement (STAR) devices. According to the FDA, the...more

Cadwalader, Wickersham & Taft LLP

White Collar Crime Law Enforcement in a Trump Justice Department - 8 Predictions

After a conventional presidential campaign, determining the policy priorities and direction of the incoming administration with respect to the Justice Department’s white collar law enforcement responsibilities can be a...more

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