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Title: White Collar Law & Investigations

Publisher:  kwebb123
Message frequency:  0.12 / day

Message History

Drawing the Line on Product Support: District of Massachusetts Rejects AKS Claims Against Manufacturer’s Infusible B...

Key Takeaways

On September 30, 2026, the District of Massachusetts granted summary judgment to Janssen Biotech and denied the relator’s cross-motion, finding insufficient evidence of either unlawful remuneration or knowing and willful conduct under the AKS. Courts continue to apply the HHS-OIG “substantial independent value” framework: product-sup...

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D.C. Circuit Upholds Broad AKS Reach, Strikes Down HHS Advisory Opinion Timing Rules: Key Takeaways from Vertex Phar...
The decision carries practical consequences for life sciences companies that rely on patient support programs and the advisory opinion process.

Key Takeaways HHS’s regulatory tolling of the 60-day advisory opinion deadline has been struck down as contrary to law. The agency must now issue opinions within 60 days of receiving a request...

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DOJ Revises Justice Manual To Strengthen False Claims Act Enforcement

Key Takeaways

The DOJ has revised two sections of the Justice Manual—Section 1-19.000 (Limitations on Issuance and Use of Guidance Documents) and Section 4-4.111 (DOJ Dismissal of a Civil Qui Tam Action)—signaling a renewed emphasis on fair notice and transparent enforcement under the False Claims Act. The guidance document revisions place strict ...

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FinCEN Finalizes Rule Eliminating Beneficial Ownership Reporting Requirements for U.S. Companies and U.S. Persons Un...
This alert is a part of a series discussing efforts the federal government is taking to modernize the Bank Secrecy Act. Foley Hoag LLP will continue to track and discuss further developments.

What to Know FinCEN’s final rule makes permanent the March 2025 changes that removed beneficial ownership information (“BOI”) reporting obligati...

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Securities Enforcement Under Chairman Atkins

A little more than halfway into the SEC’s first full year under the leadership of its Chairman, Paul Atkins, recent SEC actions give a glimmer into possible emerging trends in enforcement. In the areas of financial statement regulation and insider trading policing, the SEC is returning to basics, stepping back from some more expansive and aggressive theories of liability that...


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