Expert Analysis

• DOJ Innovasis Settlement Offers Lessons On Self-Disclosure

  

  The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.

• How Orange Book Antitrust Scrutiny Is Intensifying

  

  Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

• What To Know As Children's Privacy Law Rapidly Evolves

  

  If your business hasn't been paying attention to growing state and federal efforts to protect children online, now is the time to start — there is no sign of this regulation slowing down, and more aggressive enforcement actions are to be expected in the coming year, says Susan Rohol at Willkie Farr.

• Weight-Loss Drugs May Spur Next Major Mass Tort

  

  With lawsuits concerning Ozempic and similar weight-loss drugs potentially becoming the next major mass tort in the U.S., companies should consider key defense strategies ranging from alternate dispute resolution to enhanced drug safety, say Dino Haloulos and Jarif Khan at Foley & Mansfield.

• Opinion

  OFAC Sanctions Deserve To Be Challenged Post-Chevron

  

  The U.S. Supreme Court's Loper Bright decision opens the door to challenges against the Office of Foreign Assets Control's sanctions regime, the unintended consequences of which raise serious questions about the wisdom of what appears to be a scorched-earth approach, says Solomon Shinerock at Lewis Baach.

• Tips For Lenders Offering Texas Home Equity Lines Of Credit

  

  As interest in home equity lines of credit increases, lenders seeking to utilize such products in Texas must be aware of state-specific requirements and limitations that can make it challenging to originate open-end lines of credit on homestead property, says Tye McWhorter at Polunsky Beitel.

• Behind The Delay Of Final HSR Premerger Filing Rules

  

  Erin Toomey at Epiq discusses the wait for the final version of the revised Hart-Scott-Rodino premerger filing requirements that were first introduced in June 2023, the factors that might be behind the delay, and how to plan for the potential data-focused rule change

• Opinion

  After Jarkesy, IRS Must Course-Correct On Captive Insurance

  

  The U.S. Supreme Court’s recent Securities and Exchange Commission v. Jarkesy decision has profound implications for other agencies, including the IRS, which must stop ignoring due process and curtailing congressional intent in its policing of captive insurance arrangements, says Peter Dawson at the 831(b) Institute.

• Congress Quietly Amends FEPA: What Cos. Should Do Now

  

  Last week, Congress revised the Foreign Extortion Prevention Act — passed last year to criminalize demand-side foreign bribery — to address inconsistencies and better harmonize the law with the Foreign Corrupt Practices Act, and companies should review their compliance programs accordingly, say Mark Mendelsohn and Benjamin Klein at Paul Weiss.

• Why FDIC Banks May Want To Consider Fed Membership

  

  With the Federal Deposit Insurance Corp. recently ratcheting up bank supervision and proposing idiosyncratic new policies, state-chartered nonmember banks may want to explore the benefits of becoming Federal Reserve members and consider practical steps to make the switch, say Max Bonici and Connor Webb at Venable.

• Bid Protest Spotlight: Standing, Prejudice, Conflicts

  

  In this month's bid protest roundup, Caitlin Crujido at MoFo examines three recent decisions from the U.S. Government Accountability Office concerning whether a would-be protestor was an interested party with standing, whether an agency adequately investigated potential procurement violations and whether a proposed firewall sufficiently addressed an impaired objectivity organizational conflict of interest.

• Dissecting Treasury's Call For Input On AI In Financial Sector

  

  The U.S. Department of the Treasury's request for comments on the potential benefits and challenges AI may pose to the financial services sector, which asks how stakeholders are addressing and mitigating increased fraud risks, reflects the federal government's continued interest in AI's effects across the economy, say attorneys at Hogan Lovells.

• How Contractors Can Prep For DOD Cybersecurity Rule

  

  The proverbial clock is ticking for defense contractors and subcontractors to strengthen their compliance posture in preparation for the rollout of the highly anticipated Cybersecurity Maturity Model Certification program, so those affected should analyze their existing security standards and take proactive steps to fill in any significant gaps, say Beth Waller and Patrick Austin at Woods Rogers.

• NYSE Delisting May Be The Cost Of FCPA Compliance

  

  ABB’s recent decision to delist its U.S. depository receipts from the New York Stock Exchange, coupled with having settled three Foreign Corrupt Practices Act enforcement actions, begs the question of whether the cost of FCPA compliance should factor into a company's decision to remain listed in the U.S., says John Joy at FTI Law.

• Opinion

  The FTC Needs To Challenge The Novo-Catalent Deal

  

  Novo's acquisition of Catalent threatens to substantially lessen competition in the manufacturing and marketing of GLP-1 diabetes and obesity drugs, and the Federal Trade Commission should challenge it under a vertical theory of harm, as it aligns with last year's merger guidelines and the Fifth Circuit decision in Illumina, says attorney David Balto.