DROPLETS
The Justice Department’s Fraud Division released Directive 26‑12, outlining a new framework that rewards early corporate transparency in fraud investigations.
NFED’s Directive 26‑12, published October 1, 2026, redefines corporate fraud enforcement by focusing on key policy areas—finance, consumer protection, data security—and introduces a self‑disclosure incentive that can reduce penalties for companies reporting misconduct early. The policy states that voluntary disclosures made within two months of detection may qualify for a penalty credit or waivers, depending on cooperation level and case severity. It also specifies investigative procedures and evidentiary standards that firms must follow. Commercial law practitioners should advise clients to tighten internal reporting systems, document potential red flags, and conduct timely investigations to meet these new thresholds. The directive signals a broader DOJ appetite for corporate cooperation, which may shape future litigation strategies in antitrust and securities, and requires firms to update compliance playbooks and counsel training accordingly.
The bill requires employers to conduct independent impact analyses before deploying AI to prevent discrimination, imposing strict notice and data‑rights obligations.
The Fair AI Regulations (FAIR) Act, S4075, was cleared by the New Jersey Senate Labor Committee and would take effect 18 months after passage. It targets electronic monitoring tools, automated employment decision systems, and automated benefit systems, clearly defining “terms or conditions of employment” to include wages, work schedules, and performance reviews. Employers must obtain an independent impact assessment confirming the tool’s purpose and minimal data use before deployment and within six months for existing tools. Written notice to employees and unions is mandatory 60 days prior to deployment and for significant changes, with a 30‑day window for union concerns. Human reviewers must be authorized to override AI‑generated decisions, and adverse action solely based on AI data is prohibited. Data retention is capped at 37 months unless consented longer, and data breaches must be reported within 48 hours. Employees can access and correct their data annually and appeal adverse decisions within 30 days. Violations expose employers to fines, jail, and private lawsuits. The act rep
…
The new measure, signed Sept. 30, expands licensing duties, imposing stricter compliance on commercial financing providers and brokers across the state.
California’s newly enacted Assembly Bill 2116 expands the state’s oversight of the commercial financing sector by imposing licensing requirements on a broad spectrum of finance providers and brokers. Signed into law on September 30, the bill defines qualified entities—including in‑house financing units, independent broker firms, and outsourcing arrangements—and mandates that each obtain a license from the Department of Financial Protection and Innovation. Compliance will involve background checks, financial disclosures, and ongoing record‑keeping, with the state setting up a monitoring program and enforcement penalties for non‑compliance. For firms representing U.S. and foreign clients that engage in lending or structured finance in California, the rule necessitates a rapid review of current licensing status and the implementation of new compliance protocols. Anticipated changes also extend to capital‑based assistance advisors, who must now register and comply with disclosure requirements. The law stipulates a 90‑day window for applying, with provisions for exemptions and special arr
…
CMS-5545-F implements the mandatory GLOBE model under SSA section 1115A, benchmarking Medicare Part B drug payments against international reference prices.
What happened: On September 30, 2026, CMS issued final rule CMS-5545-F at 42 C.F.R. Part 513, implementing the Global Benchmark for Efficient Drug Pricing (GLOBE) Model — a mandatory Medicare payment model authorized under Social Security Act section 1115A. The framework ties Part B drug payment amounts to international reference benchmarks rather than domestic pricing alone.
Why sophisticated counsel and clients care: Part B covers physician-administered and certain infused biologics and oncology drugs, so a benchmarking mechanism anchored to foreign prices touches reimbursement planning, pricing and rebate compliance, government price reporting, and distribution arrangements for a broad set of manufacturer and provider clients. A mandatory model, rather than a voluntary demonstration, also raises operational questions — contract terms, chargeback and rebate mechanics, and internal controls across pricing, finance and compliance teams — and how the model interacts with existing Medicare negotiation authorities and ASP-based payment methodologies. The broader signal is a continued f
…
A federal district court in Oregon granted partial summary judgment to 22 states and D.C. in State of New York v. Vought, No. 6:25-cv-02384-AA (D. Or.), rejecting the CFPB Director's bid to void state funding transfers.
On September 25, 2026, the U.S. District Court for the District of Oregon granted partial summary judgment to a coalition of twenty-two states and the District of Columbia in State of New York v. Vought, No. 6:25-cv-02384-AA (D. Or.), declining to zero out funds those states had transferred to the Consumer Financial Protection Bureau. The ruling rejects the CFPB Director's bid to treat payments from state regulators to the bureau as voidable, touching the scope of federal preemption as applied to cooperative funding arrangements between state agencies and a federal regulator. The reported disposition appears partial, so the fate of remaining claims is unclear on available reporting.
…
The FCC votes October 29 on rules confining RF device testing, certification and lab accreditation to the US and MRA partner economies, with a December 1, 2028 cutoff and no waiver process.
On October 29 the FCC will vote on a Third Report and Order and FNPRM confining equipment authorization testing, certification and accreditation to the US and territories of economies with a US Mutual Recognition Agreement or comparable reciprocal arrangement. The bar on recognising non-MRA test labs, TCBs and accreditation bodies would apply to applications filed on or after December 1, 2028; earlier grants and pending applications are unaffected.
The rules reach past location: a TCB could not evaluate applications, make certification decisions or conduct post-market surveillance from a nonreciprocal economy, labs could not run tests there, and accreditation bodies could not accredit labs. Pre-compliance and R&D testing not relied on in a certification application falls outside the restriction. The FCC declined any waiver or case-by-case exception process, so individual relief should not be assumed.
…
A reported D.C. Circuit ruling leaves PFOS and PFOA classified as CERCLA hazardous substances, restoring federal cleanup and cost-recovery exposure across PFAS value chains.
Per a single published alert, the U.S. Court of Appeals for the D.C. Circuit has upheld EPA's final hazardous-substance rule designating PFOS and PFOA under CERCLA section 304. The practical significance is that the designation reopens the full CERCLA toolkit — cost recovery, contribution, information-gathering orders, and government-funder enforcement — for two compounds used historically in foams, firefighting, metal plating, fluorochemicals, textiles, and food packaging, among many other supply chains.
For major-firm clients, the decision converts a contested regulatory position into settled federal liability. Companies with historic sites, former operators, or indemnities tied to PFAS exposure face an expanding universe of claimants: state agencies, water utilities, and private parties in cost-recovery actions, plus successors acquiring businesses or sites with legacy PFAS use. Because CERCLA liability attaches at the release level and can reach current owners, corporate transaction diligence and post-closing indemnity structuring remain central workstreams.
…
The Supreme Court heard argument in Anderson v. Intel, asking whether a plaintiff must plead an ERISA plan underperformed a meaningful benchmark to state an unwise-investment-prudence claim.
In Anderson v. Intel Corp. Investment Policy Committee (No. 25-498), the U.S. Supreme Court heard argument on whether a participant or beneficiary alleging that an ERISA plan was imprudent in choosing an underperforming investment must plead failure to meet a "meaningful benchmark" standard. The question matters because it goes to the plausibility threshold for excessive-prudence-style claims built on comparative investment performance rather than a process-based theory; one firm reports the Court appeared receptive to a more demanding pleading standard, but argument is not a holding and no reasoning is yet operative.
Sophisticated counsel should care because defined-contribution plan sponsors, 401(k) committees, recordkeepers, and plan advisers face a shifting exposure map. If a heightened benchmark requirement is confirmed, a substantial volume of performance-based ERISA actions could face earlier dismissal, affecting reserve decisions, recordkeeper fee leverage, and the value of plan-governance documentation.
…
The Comisión Nacional de Energía revised its methodology for determining charges, clarifying exception periods and key considerations.
On Sept. 30, 2026 the Diario Oficial de la Federación published the Comisión Nacional de Energía’s (CNE) revised methodology for determining energy‑market charges. The update tightens the definition of the exception period and adds several new calculations that could raise or lower tariffs for electricity suppliers, bilateral traders, and load‑management vendors operating in Mexico. Counsel should review the new formulae against current billing contracts, assess whether close‑dated agreements will be affected, and adjust any automated invoicing systems accordingly. Firms with cross‑border or multinational energy portfolios should flag the changes to client risk teams and consider engaging with CNE to confirm the application of the clarified methodology under their specific market segments. The immediate operational impact is a potential shift in cost structures; a subsequent monitoring of CNE’s guidance forum will be prudent to capture any further clarifications or supplementary schedules.
California has signed what Sheppard Mullin calls landmark AI workplace laws on automated termination, layoffs and monitoring; the alert does not name the statutes or effective dates.
According to Sheppard Mullin, California has signed what the firm calls landmark AI workplace laws covering automated termination decisions, layoff-related decision-making and workplace surveillance. The available alert names no bills, statutory sections, agency guidance or effective dates, and does not separate enacted statutes from pending rules.
Why counsel should care: California's FEHA already reaches automated decision-making bias in hiring, promotion and termination. Additional stand-alone duties typically impose procedural requirements — notice that automated systems are in use, human review or appeal rights, and sometimes retention of or access to monitoring data — that reach every employer with a California-exposed workforce. A termination routed through an algorithmic pipeline without compliant notice or review can invite statutory liability and, depending on the provision, attorney's-fee exposure.
…
The SEC's October 1, 2026 proposal would substantially rewrite the registered investment adviser custody rule and amend the Investment Company Act to address digital assets, reshaping how advisers safeguard client crypto holdings.
On October 1, 2026 the SEC proposed rules and amendments under the Investment Advisers Act of 1940 and the Investment Company Act of 1940 that would materially revise the adviser custody framework as applied to digital assets. Reporting indicates the proposal makes sweeping changes to the existing custody rule — the requirement that advisers holding client securities maintain them with a qualified custodian in a segregated account subject to reasonable verification.
Several obligations intersect here: which custodians qualify, how client property is held and verified, and how advisers address assets for which a qualified custodian may not exist. Comment deadlines, transition periods and any grandfathering are the operative details to extract from the releasing text, which is not in the available source material.
…
The Eleventh Circuit affirmed AKS convictions in United States v. Chun, adopting the Fifth Circuit's knowledge formulation of the statute's scienter requirement and clarifying what the prosecution must prove.
On August 18, 2026, the Eleventh Circuit affirmed two defendants' convictions and sentences for violating the federal Anti-Kickback Statute in United States v. Chun, adopting the Fifth Circuit's knowledge standard for the AKS's scienter requirement. The decision matters because the AKS reaches broadly through its referral-source and remuneration provisions, and the scienter showing is a principal defense line in prosecutions involving pharmaceutical manufacturers, distributors, and physicians.
Two points drive the practical significance. First, alignment with the Fifth Circuit reduces forum-dependent variation and gives defense counsel a more settled map when weighing where a case will be litigated. Second, because the AKS is effectively strict liability in form, the knowledge requirement is a recurring battleground, and a clarified standard on that element affects what the government must prove at trial and on appeal.
…
EPA's September 25, 2026 final rule would sharply limit how third parties can use Clean Air Act Title V permitting to reopen New Source Review determinations.
On September 25, 2026, the U.S. Environmental Protection Agency published a final rule that significantly limits the ability of third parties to use the Clean Air Act Title V permitting process to revisit New Source Review determinations.
Why sophisticated counsel should care: Title V permits are the standard vehicle industry groups, environmental organizations and states have long used to revisit NSR conclusions years after the original pre-construction permit — the classic route for neighbors or challengers to argue that a new or modified source triggered avoidable or unlawful emission increases. A rule that narrows that pathway reshapes litigation leverage around pending and future permit challenges, not just those in the rulemaking docket.
…
Generative AI tools route unreleased scripts, schedules, and proprietary data into hidden prompt histories, threatening to leak trade secrets traditionally protected by contracts and secrecy.
Entertainment firms rely on secrecy to protect creative assets. As workers use generative AI, confidential material can be unintentionally ingested or outputted by third‑party platforms, exposing trade secrets. The guide outlines an AI‑aware confidentiality framework: vet AI platforms, update NDAs to cover AI submissions, enforce access controls, provide AI‑specific training, conduct vendor diligence, and strengthen off‑boarding to review prompt histories. In states like California with limited non‑competes, robust trade secret safeguards become essential. Firms should treat AI as a data processing actor, embed protections in AI governance, and monitor vendor terms as the technology evolves. Additionally, firms should periodically audit AI platform agreements for data retention clauses, and consider on‑premise AI solutions for highly sensitive workflows. Legal counsel should review any AI‑generated content as potential trade secret material and incorporate data handling controls into contract language with vendors. Monitoring the evolving regulatory landscape around AI data use will
…
NY’s new statute now obligates employers to provide employees with their personnel files within five days and issue notices on any ‘negative information’, with penalties up to $2,500 per breach.
New York’s personnel record access law, effective November 8, 2026, expands statutory rights for current and former employees to obtain copies of file records that influence hiring, promotion, or discipline, at no cost and within five business days. Employers must also give a written notice within ten days of adding any information that could negatively affect an employee’s employment prospects; the rule applies to records held by third‑party vendors such as PEOs or payroll firms. Violations carry fines of $500 to $2,500 per breach, and retaliation against employees exercising these rights is prohibited. Firms should immediately audit existing personnel‑record policies, establish a robust request‑processing workflow, and develop clear criteria for identifying and notifying employees about negative data. Training for HR, managers, and compliance staff should cover the new notice and anti‑retaliation provisions, and employers should monitor potential legislative amendments that may refine record creation or content definitions in the 2027 session.
The SEC's October 7, 2026 report of investigation signals how activist and collaborative investor engagement with external organizations could trigger beneficial-ownership group status under Section 13(d).
The SEC issued a report of investigation on October 7, 2026 addressing when an investor's engagement with a multistakeholder initiative could cause that investor to be treated as part of a "group" for Section 13(d) beneficial ownership purposes. The framing is deliberately broader than ESG: it reaches collaborative engagement mechanisms generally, which is why securities lawyers expect issuers and investors to revisit how governance and sustainability dialogue is structured.
Why sophisticated counsel should care: Section 13(d) group status carries real consequences — disclosure obligations, activist tactics, and deal dynamics for issuers, directors, and hedge funds alike. A report of investigation also signals enforcement posture, and the "further re-evaluation" language implies that issuers and investors who have already been designing engagement practices should audit them again.
…
The court rejects a fair‑use defense, ruling Westlaw headnotes are protected works.
On Sept. 29, 2026 the Third Circuit affirmed the District Court’s partial summary judgment that Westlaw headnotes are copyrightable. In Thomson Reuters Enterprise Centre GmbH v. Ross Intelligence, the panel held the short legal summaries attached to Westlaw cases fall outside the narrow fair‑use exception for commentary or criticism, making unlicensed use in client filings or internal documents infringing. The decision does not invalidate the use of Westlaw for research itself, but it bars firms from reproducing or incorporating headnotes without a license. Law practitioners should audit all Westlaw-derived content in pleadings, briefs and discovery to ensure compliance, and consider drafting custom headnote‑style notes under their own copyright. The ruling may serve as precedent for future disputes over copyright in research metadata, prompting a reassessment of how firms treat and license such ancillary content.
The Justice Department’s Fraud Division released Directive 26‑12, outlining a new framework that rewards early corporate transparency in fraud investigations.
NFED’s Directive 26‑12, published October 1, 2026, redefines corporate fraud enforcement by focusing on key policy areas—finance, consumer protection, data security—and introduces a self‑disclosure incentive that can reduce penalties for companies reporting misconduct early. The policy states that voluntary disclosures made within two months of detection may qualify for a penalty credit or waivers, depending on cooperation level and case severity. It also specifies investigative procedures and evidentiary standards that firms must follow. Commercial law practitioners should advise clients to tighten internal reporting systems, document potential red flags, and conduct timely investigations to meet these new thresholds. The directive signals a broader DOJ appetite for corporate cooperation, which may shape future litigation strategies in antitrust and securities, and requires firms to update compliance playbooks and counsel training accordingly.
The bill requires employers to conduct independent impact analyses before deploying AI to prevent discrimination, imposing strict notice and data‑rights obligations.
The Fair AI Regulations (FAIR) Act, S4075, was cleared by the New Jersey Senate Labor Committee and would take effect 18 months after passage. It targets electronic monitoring tools, automated employment decision systems, and automated benefit systems, clearly defining “terms or conditions of employment” to include wages, work schedules, and performance reviews. Employers must obtain an independent impact assessment confirming the tool’s purpose and minimal data use before deployment and within six months for existing tools. Written notice to employees and unions is mandatory 60 days prior to deployment and for significant changes, with a 30‑day window for union concerns. Human reviewers must be authorized to override AI‑generated decisions, and adverse action solely based on AI data is prohibited. Data retention is capped at 37 months unless consented longer, and data breaches must be reported within 48 hours. Employees can access and correct their data annually and appeal adverse decisions within 30 days. Violations expose employers to fines, jail, and private lawsuits. The act rep
…
The Supreme Court heard argument in Anderson v. Intel, asking whether a plaintiff must plead an ERISA plan underperformed a meaningful benchmark to state an unwise-investment-prudence claim.
In Anderson v. Intel Corp. Investment Policy Committee (No. 25-498), the U.S. Supreme Court heard argument on whether a participant or beneficiary alleging that an ERISA plan was imprudent in choosing an underperforming investment must plead failure to meet a "meaningful benchmark" standard. The question matters because it goes to the plausibility threshold for excessive-prudence-style claims built on comparative investment performance rather than a process-based theory; one firm reports the Court appeared receptive to a more demanding pleading standard, but argument is not a holding and no reasoning is yet operative.
Sophisticated counsel should care because defined-contribution plan sponsors, 401(k) committees, recordkeepers, and plan advisers face a shifting exposure map. If a heightened benchmark requirement is confirmed, a substantial volume of performance-based ERISA actions could face earlier dismissal, affecting reserve decisions, recordkeeper fee leverage, and the value of plan-governance documentation.
…
California has signed what Sheppard Mullin calls landmark AI workplace laws on automated termination, layoffs and monitoring; the alert does not name the statutes or effective dates.
According to Sheppard Mullin, California has signed what the firm calls landmark AI workplace laws covering automated termination decisions, layoff-related decision-making and workplace surveillance. The available alert names no bills, statutory sections, agency guidance or effective dates, and does not separate enacted statutes from pending rules.
Why counsel should care: California's FEHA already reaches automated decision-making bias in hiring, promotion and termination. Additional stand-alone duties typically impose procedural requirements — notice that automated systems are in use, human review or appeal rights, and sometimes retention of or access to monitoring data — that reach every employer with a California-exposed workforce. A termination routed through an algorithmic pipeline without compliant notice or review can invite statutory liability and, depending on the provision, attorney's-fee exposure.
…
NY’s new statute now obligates employers to provide employees with their personnel files within five days and issue notices on any ‘negative information’, with penalties up to $2,500 per breach.
New York’s personnel record access law, effective November 8, 2026, expands statutory rights for current and former employees to obtain copies of file records that influence hiring, promotion, or discipline, at no cost and within five business days. Employers must also give a written notice within ten days of adding any information that could negatively affect an employee’s employment prospects; the rule applies to records held by third‑party vendors such as PEOs or payroll firms. Violations carry fines of $500 to $2,500 per breach, and retaliation against employees exercising these rights is prohibited. Firms should immediately audit existing personnel‑record policies, establish a robust request‑processing workflow, and develop clear criteria for identifying and notifying employees about negative data. Training for HR, managers, and compliance staff should cover the new notice and anti‑retaliation provisions, and employers should monitor potential legislative amendments that may refine record creation or content definitions in the 2027 session.
The Comisión Nacional de Energía revised its methodology for determining charges, clarifying exception periods and key considerations.
On Sept. 30, 2026 the Diario Oficial de la Federación published the Comisión Nacional de Energía’s (CNE) revised methodology for determining energy‑market charges. The update tightens the definition of the exception period and adds several new calculations that could raise or lower tariffs for electricity suppliers, bilateral traders, and load‑management vendors operating in Mexico. Counsel should review the new formulae against current billing contracts, assess whether close‑dated agreements will be affected, and adjust any automated invoicing systems accordingly. Firms with cross‑border or multinational energy portfolios should flag the changes to client risk teams and consider engaging with CNE to confirm the application of the clarified methodology under their specific market segments. The immediate operational impact is a potential shift in cost structures; a subsequent monitoring of CNE’s guidance forum will be prudent to capture any further clarifications or supplementary schedules.
A reported D.C. Circuit ruling leaves PFOS and PFOA classified as CERCLA hazardous substances, restoring federal cleanup and cost-recovery exposure across PFAS value chains.
Per a single published alert, the U.S. Court of Appeals for the D.C. Circuit has upheld EPA's final hazardous-substance rule designating PFOS and PFOA under CERCLA section 304. The practical significance is that the designation reopens the full CERCLA toolkit — cost recovery, contribution, information-gathering orders, and government-funder enforcement — for two compounds used historically in foams, firefighting, metal plating, fluorochemicals, textiles, and food packaging, among many other supply chains.
For major-firm clients, the decision converts a contested regulatory position into settled federal liability. Companies with historic sites, former operators, or indemnities tied to PFAS exposure face an expanding universe of claimants: state agencies, water utilities, and private parties in cost-recovery actions, plus successors acquiring businesses or sites with legacy PFAS use. Because CERCLA liability attaches at the release level and can reach current owners, corporate transaction diligence and post-closing indemnity structuring remain central workstreams.
…
EPA's September 25, 2026 final rule would sharply limit how third parties can use Clean Air Act Title V permitting to reopen New Source Review determinations.
On September 25, 2026, the U.S. Environmental Protection Agency published a final rule that significantly limits the ability of third parties to use the Clean Air Act Title V permitting process to revisit New Source Review determinations.
Why sophisticated counsel should care: Title V permits are the standard vehicle industry groups, environmental organizations and states have long used to revisit NSR conclusions years after the original pre-construction permit — the classic route for neighbors or challengers to argue that a new or modified source triggered avoidable or unlawful emission increases. A rule that narrows that pathway reshapes litigation leverage around pending and future permit challenges, not just those in the rulemaking docket.
…
The new measure, signed Sept. 30, expands licensing duties, imposing stricter compliance on commercial financing providers and brokers across the state.
California’s newly enacted Assembly Bill 2116 expands the state’s oversight of the commercial financing sector by imposing licensing requirements on a broad spectrum of finance providers and brokers. Signed into law on September 30, the bill defines qualified entities—including in‑house financing units, independent broker firms, and outsourcing arrangements—and mandates that each obtain a license from the Department of Financial Protection and Innovation. Compliance will involve background checks, financial disclosures, and ongoing record‑keeping, with the state setting up a monitoring program and enforcement penalties for non‑compliance. For firms representing U.S. and foreign clients that engage in lending or structured finance in California, the rule necessitates a rapid review of current licensing status and the implementation of new compliance protocols. Anticipated changes also extend to capital‑based assistance advisors, who must now register and comply with disclosure requirements. The law stipulates a 90‑day window for applying, with provisions for exemptions and special arr
…
A federal district court in Oregon granted partial summary judgment to 22 states and D.C. in State of New York v. Vought, No. 6:25-cv-02384-AA (D. Or.), rejecting the CFPB Director's bid to void state funding transfers.
On September 25, 2026, the U.S. District Court for the District of Oregon granted partial summary judgment to a coalition of twenty-two states and the District of Columbia in State of New York v. Vought, No. 6:25-cv-02384-AA (D. Or.), declining to zero out funds those states had transferred to the Consumer Financial Protection Bureau. The ruling rejects the CFPB Director's bid to treat payments from state regulators to the bureau as voidable, touching the scope of federal preemption as applied to cooperative funding arrangements between state agencies and a federal regulator. The reported disposition appears partial, so the fate of remaining claims is unclear on available reporting.
…
The SEC's October 1, 2026 proposal would substantially rewrite the registered investment adviser custody rule and amend the Investment Company Act to address digital assets, reshaping how advisers safeguard client crypto holdings.
On October 1, 2026 the SEC proposed rules and amendments under the Investment Advisers Act of 1940 and the Investment Company Act of 1940 that would materially revise the adviser custody framework as applied to digital assets. Reporting indicates the proposal makes sweeping changes to the existing custody rule — the requirement that advisers holding client securities maintain them with a qualified custodian in a segregated account subject to reasonable verification.
Several obligations intersect here: which custodians qualify, how client property is held and verified, and how advisers address assets for which a qualified custodian may not exist. Comment deadlines, transition periods and any grandfathering are the operative details to extract from the releasing text, which is not in the available source material.
…
CMS-5545-F implements the mandatory GLOBE model under SSA section 1115A, benchmarking Medicare Part B drug payments against international reference prices.
What happened: On September 30, 2026, CMS issued final rule CMS-5545-F at 42 C.F.R. Part 513, implementing the Global Benchmark for Efficient Drug Pricing (GLOBE) Model — a mandatory Medicare payment model authorized under Social Security Act section 1115A. The framework ties Part B drug payment amounts to international reference benchmarks rather than domestic pricing alone.
Why sophisticated counsel and clients care: Part B covers physician-administered and certain infused biologics and oncology drugs, so a benchmarking mechanism anchored to foreign prices touches reimbursement planning, pricing and rebate compliance, government price reporting, and distribution arrangements for a broad set of manufacturer and provider clients. A mandatory model, rather than a voluntary demonstration, also raises operational questions — contract terms, chargeback and rebate mechanics, and internal controls across pricing, finance and compliance teams — and how the model interacts with existing Medicare negotiation authorities and ASP-based payment methodologies. The broader signal is a continued f
…
The Eleventh Circuit affirmed AKS convictions in United States v. Chun, adopting the Fifth Circuit's knowledge formulation of the statute's scienter requirement and clarifying what the prosecution must prove.
On August 18, 2026, the Eleventh Circuit affirmed two defendants' convictions and sentences for violating the federal Anti-Kickback Statute in United States v. Chun, adopting the Fifth Circuit's knowledge standard for the AKS's scienter requirement. The decision matters because the AKS reaches broadly through its referral-source and remuneration provisions, and the scienter showing is a principal defense line in prosecutions involving pharmaceutical manufacturers, distributors, and physicians.
Two points drive the practical significance. First, alignment with the Fifth Circuit reduces forum-dependent variation and gives defense counsel a more settled map when weighing where a case will be litigated. Second, because the AKS is effectively strict liability in form, the knowledge requirement is a recurring battleground, and a clarified standard on that element affects what the government must prove at trial and on appeal.
…
The court rejects a fair‑use defense, ruling Westlaw headnotes are protected works.
On Sept. 29, 2026 the Third Circuit affirmed the District Court’s partial summary judgment that Westlaw headnotes are copyrightable. In Thomson Reuters Enterprise Centre GmbH v. Ross Intelligence, the panel held the short legal summaries attached to Westlaw cases fall outside the narrow fair‑use exception for commentary or criticism, making unlicensed use in client filings or internal documents infringing. The decision does not invalidate the use of Westlaw for research itself, but it bars firms from reproducing or incorporating headnotes without a license. Law practitioners should audit all Westlaw-derived content in pleadings, briefs and discovery to ensure compliance, and consider drafting custom headnote‑style notes under their own copyright. The ruling may serve as precedent for future disputes over copyright in research metadata, prompting a reassessment of how firms treat and license such ancillary content.
The Justice Department’s Fraud Division released Directive 26‑12, outlining a new framework that rewards early corporate transparency in fraud investigations.
NFED’s Directive 26‑12, published October 1, 2026, redefines corporate fraud enforcement by focusing on key policy areas—finance, consumer protection, data security—and introduces a self‑disclosure incentive that can reduce penalties for companies reporting misconduct early. The policy states that voluntary disclosures made within two months of detection may qualify for a penalty credit or waivers, depending on cooperation level and case severity. It also specifies investigative procedures and evidentiary standards that firms must follow. Commercial law practitioners should advise clients to tighten internal reporting systems, document potential red flags, and conduct timely investigations to meet these new thresholds. The directive signals a broader DOJ appetite for corporate cooperation, which may shape future litigation strategies in antitrust and securities, and requires firms to update compliance playbooks and counsel training accordingly.
The SEC's October 7, 2026 report of investigation signals how activist and collaborative investor engagement with external organizations could trigger beneficial-ownership group status under Section 13(d).
The SEC issued a report of investigation on October 7, 2026 addressing when an investor's engagement with a multistakeholder initiative could cause that investor to be treated as part of a "group" for Section 13(d) beneficial ownership purposes. The framing is deliberately broader than ESG: it reaches collaborative engagement mechanisms generally, which is why securities lawyers expect issuers and investors to revisit how governance and sustainability dialogue is structured.
Why sophisticated counsel should care: Section 13(d) group status carries real consequences — disclosure obligations, activist tactics, and deal dynamics for issuers, directors, and hedge funds alike. A report of investigation also signals enforcement posture, and the "further re-evaluation" language implies that issuers and investors who have already been designing engagement practices should audit them again.
…
The FCC votes October 29 on rules confining RF device testing, certification and lab accreditation to the US and MRA partner economies, with a December 1, 2028 cutoff and no waiver process.
On October 29 the FCC will vote on a Third Report and Order and FNPRM confining equipment authorization testing, certification and accreditation to the US and territories of economies with a US Mutual Recognition Agreement or comparable reciprocal arrangement. The bar on recognising non-MRA test labs, TCBs and accreditation bodies would apply to applications filed on or after December 1, 2028; earlier grants and pending applications are unaffected.
The rules reach past location: a TCB could not evaluate applications, make certification decisions or conduct post-market surveillance from a nonreciprocal economy, labs could not run tests there, and accreditation bodies could not accredit labs. Pre-compliance and R&D testing not relied on in a certification application falls outside the restriction. The FCC declined any waiver or case-by-case exception process, so individual relief should not be assumed.
…
Generative AI tools route unreleased scripts, schedules, and proprietary data into hidden prompt histories, threatening to leak trade secrets traditionally protected by contracts and secrecy.
Entertainment firms rely on secrecy to protect creative assets. As workers use generative AI, confidential material can be unintentionally ingested or outputted by third‑party platforms, exposing trade secrets. The guide outlines an AI‑aware confidentiality framework: vet AI platforms, update NDAs to cover AI submissions, enforce access controls, provide AI‑specific training, conduct vendor diligence, and strengthen off‑boarding to review prompt histories. In states like California with limited non‑competes, robust trade secret safeguards become essential. Firms should treat AI as a data processing actor, embed protections in AI governance, and monitor vendor terms as the technology evolves. Additionally, firms should periodically audit AI platform agreements for data retention clauses, and consider on‑premise AI solutions for highly sensitive workflows. Legal counsel should review any AI‑generated content as potential trade secret material and incorporate data handling controls into contract language with vendors. Monitoring the evolving regulatory landscape around AI data use will
…
Grade 3 — worth a glance, not the full analysis.
- Australia Moves to Criminalise Match‑Fixing – New Bill Adds 7 Offences
The Senate committee’s recommendation introduces a full suite of match‑fixing crimes, extending beyond betting and aligning domestic law with the international Macolin Convention.
- DOL Repeats Decision, Keeps 450+ FLSA Interpretive Rules in CFR
The Department of Labor has abandoned its plan to strip more than 450 long‑standing FLSA interpretive rules, preserving familiar guidance employers rely on for compliance.
- Law Firms Brace for Surge in Congressional Probes Post‑Midterms
Big Law firms are expanding congressional investigations practices as they prepare for a wave of congressional inquiries following the 2026 midterm elections.
- Claim Counting Nuances in IPRs Could Affect Tocilizumab Patent Strategy
Venable’s recent analysis explains how the same claim can be counted multiple times across IPRs, a nuance that could shift how drug patents are challenged.
- Franchisor May Recover Lost Profits in Minnesota Termination Case
The U.S. District Court for Minnesota ruled that a franchisee’s premature termination of a franchise agreement can entitle the franchisor to actual lost‑profit damages under state law.
- ESMA Releases 2026 Trends, Risks and Vulnerabilities Report
The EU market watchdog publishes its second annual report mapping emerging threats across securities markets for 31 Dec 2025–30 Jun 2026.
- NY Lawmakers Propose New Regulations for Artificial Turf
The bill would regulate manufacturing, sale, installation, and disposal of artificial turf, potentially reshaping the industry’s compliance landscape.
- FTC Settles With Nuvei and Humboldt Over Facilitating Merchant Fraud
The FTC says it settled with two payment processors, Nuvei and Humboldt Merchant Services, treating processors as the practical chokepoint for reaching domestic and foreign merchants that defraud consumers.
- FDIC Proposes Parity Rule for State Banks in Interstate Services
The FDIC has issued a proposal that would give state-chartered banks parity with national banks for interstate services, a rulemaking worth tracking for banking and regulatory counsel.
- Federal Reserve Extends Comment Period on Regulation O Insider Lending Proposal
The Federal Reserve announced on October 2 that it is extending by 30 days the comment period on its proposal to update Regulation O, the rule governing bank insider lending.
- FCA Guidance Sharpens Expectations on Non-Financial Misconduct
Latham & Watkins summarises what changed in the FCA's expectations for firms handling non-financial misconduct cases, and sets out how firms can approach those cases.
- Nasdaq Proposes Fix to Timing of $5 Million MVLS Continued Listing Rule
On October 5, 2026 the SEC published notice of a Nasdaq rule change filed September 25, 2026, meant to resolve timing uncertainty left by the stay of Nasdaq's $5 million MVLS continued listing requirement.
- Washington AG Releases First Data Privacy Report on Enforcement
The Washington State Attorney General's office published its first Data Privacy Report in August 2026, offering the earliest window into the state's privacy enforcement priorities under Washington's consumer data privacy law.
- FAR 52.222-90 flow-down: the overseas delivery-or-performance exception
Ogletree Deakins reads the DEI clause's flow-down exception as disjunctive, so a product made entirely abroad and shipped FOB destination to a U.S. site may fall outside it, while mixed-location performance stays unresolved.
- SEC Proposes Adviser Custody Rule Overhaul, Adding Cryptoasset Framework
The SEC has proposed amendments to the investment adviser custody rule designed to modernize safekeeping requirements, create a custody framework for cryptoassets and address qualified custodian expectations.
- New Jersey Supreme Court ruling extends wage protections regardless of status
A Jackson Lewis attorney told Law360 that a New Jersey Supreme Court decision confirms wage-and-hour protections apply to workers regardless of immigration status, though the cluster offers no details on the holding.
- SEC Filer Status Proposal Enters Public Comment; Goodwin Maps Themes
Goodwin summarizes the themes commentors raised on the SEC's proposal to revise filer status definitions, a signal on where disclosure-scaling reform may land for large and accelerated filers.
- FCC Report and Order Opens 1,025 MHz to Satellite Broadband and eSIM
The FCC adopted omnibus item FCC 26-65 on September 30, 2026, opening 1,025 MHz to satellite broadband, NGSO/GSO networks and gateway operators — a rulemaking telecom and satellite practitioners should review.
- European leveraged loans: transfer restrictions tighten as buyers adapt
Akin Gump maps the clauses now controlling who can buy European term loans or take economic exposure: Loan to Own and Industry Competitor tests, sub-participation definitions, Net Short Lender controls and shorter approved-lender lists.
- Menopause Workplace Accommodation Duties and Health Plan Mandates
A practitioner explainer maps new state workplace-accommodation statutes and health plan insurance mandates tied to menopause, and the policy steps employers should be taking now.
- SEC Division of Examinations Publishes New Exam Handbook
On October 1, 2026 the SEC Division of Examinations released The SEC Exam Handbook: A Practical Guide on Process and Engagement, setting out the division's examination approach and engagement expectations for registrants and issuers.
- Joint OCC and Federal Reserve Consent Orders Put AML Controls on Notice
Parallel Oct. 8, 2026 consent orders against a major financial services corporation and a bank holding company signal intensified US prudential-regulator scrutiny of anti-money-laundering programmes.
- Courts wrestle with crypto price volatility in bankruptcy and criminal cases
Recent decisions explore how courts should value a crypto asset that fluctuates wildly in price.
- German Labor Court Rules Employees Cannot Unilaterally Cancel Parental Leave
The Federal Labor Court clarified that a previously requested parental leave remains binding, preventing employers from relying on unilateral withdrawal by employees before the leave starts.
- DC Cuts Paid Leave Weeks and Weekly Benefit Cap Effective October 1
Amendments to DC's Universal Paid Leave Act temporarily shorten certain paid family and medical leave durations and lower the maximum weekly benefit, affecting employer payroll contributions and leave planning.
- FTC Weighs Updating Its Government and Business Impersonation Rule
The commission is considering whether to revise its Part 461 rule or take other action as impersonation scams top its fraud complaint data; evidence shows only contemplation, not a docket or timetable.
- Australian Energy Market Update: New September 2026 Rules
Latest rule changes outlined for electricity and gas market participants.
- Baratta Departs Blackstone as JPMorgan's Cristerna Retires Same Week
A weekly growth-equity digest reports Joe Baratta will leave Blackstone at year-end with no replacement, the same week JPMorgan's long-serving M&A chief Hernan Cristerna retires.
- First draft UK Environmental Delivery Plan draws divided industry reaction
Jones Day's 13 October 2026 analysis of the UK's first draft Environmental Delivery Plan reports a split response to the proposals, signalling no settled path for affected sectors.
- New York’s Medicaid Moratorium Sparks Provider Concerns
The temporary enrollment freeze may alter provider contracts and Medicaid revenue streams.
- Indiana Ruling Threatens Email Marketers With $500‑Per‑Email Class Action Damages
An Indiana court’s decision now subjects email marketers to potentially $500 damages for every email, prompting firms to reassess their data‑use practices.