Expert Analysis

• FDA Classification Setback Bodes Well For Wound Care Cos.

  

  A Georgia federal court's recent decision in MiMedx v. U.S. Food and Drug Administration constrains the FDA's analytical framework for classifying certain wound care products as biological products, carrying important ramifications for manufacturers seeking to avoid heightened regulatory requirements, say attorneys at Hyman Phelps.

• 10 Ways AI Labs Can Limit Antitrust Risks Of Safety Pacts

  

  The OpenAI CEO’s recent call for artificial intelligence laboratories to collectively slow development to allow safety research to catch up invites antitrust scrutiny, but the risks to coordinating competitors can be managed by carefully structuring pacing agreements and layering their approach to compliance, say attorneys at Holland & Knight.

• FINRA Disputes Highlight Timeliness In Arbitrator Bias Claims

  

  Recent Financial Industry Regulatory Authority litigation over arbitrator neutrality shows that the strength of challenges depends not only on what counsel discovers, but also on how early it is uncovered and how concretely it can be demonstrated, says Dax White at White Law.

• Opinion

  A Capital Markets Agenda For The New Congress

  

  When the 120th Congress convenes in January, it should place capital markets issues near the top of its to-do list, with a focus on legislation that can make the public company model more competitive, says David Kaufman at Thompson Coburn.

• How AI Could Help Judges Spot Their Own Biases

  

  In close cases where there’s room for discretion, artificial intelligence could challenge judges’ implicit biases by running counterfactual tests at scale — but any judicial use of such tools would need guardrails, say Arnold Peter at Peter Law and Nancy Rapoport at University of Nevada.

• Assessing Hidden Risk Of Administrative Agency Settlements

  

  Though administrative resolutions of U.S. Securities and Exchange Commission investigations may seem preferable to settled federal court actions, the possibility that private plaintiffs may use commission orders in follow-on litigation poses an extra risk, increasing the importance of negotiating the settlement's form and language, say attorneys at Debevoise.

• Tracking Texas: When Counterclaims Start The Removal Clock

  

  The Texas Business Court's recent decision in Bakery v. Naterra International clarifies that, when the original claims do not meet the court's amount-in-controversy threshold, a presuit threat to bring high-value counterclaims does not itself make those unfiled claims part of the action, say attorneys at Greenberg Traurig.

• Parsing The Lowest SEC Enforcement Stats In Over A Decade

  

  Statistics show that the U.S. Securities and Exchange Commission brought a historically low number of enforcement actions during Paul Atkins' first full fiscal year as chairman, delivering on his promise to reduce enforcement in program areas focused on recordkeeping and other technical violations, say attorneys at Covington.

• Coinbase Ruling Showcases A Texas Reincorporation Benefit

  

  The Texas Business Court's recent decision in Guillaume v. Armstrong, finding that a shareholder's claims against Coinbase, originally incorporated in Delaware, are nonetheless subject to Texas presuit demand law if made after reincorporation, provides a procedural advantage for companies that have made the move, say attorneys at Cleary.

• How '21 IPO Class Can Prep For 'Emerging Growth Co.' Sunset

  

  Five years after the initial public offering boom of 2020 and 2021 brought an unusually large number of companies into the U.S. public markets, many are set to lose their status as "emerging growth companies," so they should use the next two months to build a coordinated transition plan, say attorneys at Clark Hill.

• Mass. High Court Raises Bar For Trade Secret Injunctions

  

  The Massachusetts Supreme Judicial Court's recent decision in Daikin v. Russo confirms that trade secret plaintiffs must prove irreparable harm under ordinary equitable principles when seeking a preliminary injunction, putting an end to potential theories of automatic presumption, says Gregory Bombard at Greenberg Traurig.

• New Manhattan DA Task Force Puts Antitrust In Its Crosshairs

  

  The Manhattan District Attorney's Office's new corporate crime and antitrust task force is adding local criminal enforcement to a field long led by federal authorities, meaning companies need to account for potential parallel federal and state antitrust investigations when responding to misconduct, say attorneys at Ropes & Gray.

• 3 Strategies To Reduce AI Sycophancy In Legal Work

  

  The tendency of generative artificial intelligence models to tell users what they want to hear can reinforce attorneys’ confirmation bias when testing the strength of arguments, and it can’t simply be prompted away — but a few practices can help mitigate it, says Michael Ott at Ice Miller.

• Accenture's FCA Deal Shows DEI Risks For Gov't Contractors

  

  The U.S. Department of Justice recently settled allegations that Accenture falsely certified compliance with antidiscrimination requirements in its federal contracts, underscoring how diversity goals can become a False Claims Act issue when the company requests payment from the government, say attorneys at Bass Berry.

• DOJ Directive Gives Contractors A Fraud Risk Road Map

  

  For government contractors, the 10 factors described in the U.S. Department of Justice's recent corporate fraud enforcement directive function as a de facto scoring rubric for internal audits that mirrors what prosecutors will prioritize, say attorneys at Spencer Fane.