Expert Analysis

• Pros And Cons Of FDA's Push For Nonprescription Drugs

  

  The U.S. Food and Drug Administration's recent moves to shift more prescription drugs to over-the-counter status could increase access to important medications, but also bring potential safety risks and other trade-offs for drug companies, say attorneys at Hogan Lovells.

• How Recent Del. Rulings Clarify M&A Deal Fraud Carveouts

  

  Two recent Delaware decisions have provided clarity regarding when a party can or cannot rely on representations made during the course of an M&A transaction, particularly on the scope and enforceability of antireliance provisions, and on representations they knew or should have known were false, says Anthony Boccamazzo at Olshan Frome.

• High Court's 'Skinny Label' Case May Tackle Wider Questions

  

  The U.S. Supreme Court's upcoming decision in Hikma v. Amarin will have important ramifications for broader debates over what defines a generic version of a drug, and the pending case is already altering patent practice, say attorneys at Taft.

• Aligning Microsoft Tools With NYC Bar AI Recording Guidance

  

  The New York City Bar Association’s recently issued formal opinion, providing ethical guidance on artificial intelligence-assisted recording, transcription and summarization, raises immediate questions about data governance and e-discovery for companies that use Microsoft 365 and Copilot, say Staci Kaliner, Martin Tully and John Collins at Redgrave.

• FDA's Biosimilarity Guidance Holds Uncertain Implications

  

  The U.S. Food and Drug Administration's new draft guidance aimed at simplifying the biosimilarity demonstration process may not be enough to overcome the barriers that have historically constrained biosimilar competition, and could affect biosimilar access in unexpected ways, say analysts at Analysis Group.

• Unpacking Key Themes From NY's New Healthcare Strategy

  

  New York Gov. Kathy Hochul's 2026 State of the State agenda, read together with the state's fiscal year 2027 executive budget, reflect a clear framework to utilize Medicaid as the state's operating platform for healthcare reform, say attorneys at Sheppard.

• 5 Different AI Systems Raise Distinct Privilege Issues

  

  A New York federal court’s recent U.S. v. Heppner decision, holding that a defendant’s use of Claude was not privileged, only addressed one narrow artificial intelligence system, but lawyers must recognize that the spectrum of AI tools raises different confidentiality and privilege questions, says Heidi Nadel at HP.

• Opinion

  AI-Assisted Arbitration Needs Safeguards To Ensure Fairness

  

  As tribunals and arbitral institutions increasingly use artificial intelligence tools in their decision-making processes, ​​​​​​​clear disclosure standards and procedural safeguards are necessary to ensure that efficiency gains do not erode the fairness principles on which arbitration depends, says Alexander Lima at Wesco International.

• Trans Care Enforcement Landscape Is Evolving Quickly

  

  The recent coordinated federal effort to reshape pediatric gender-affirming care through enforcement and funding pressure has created a rapidly evolving regulatory environment marked by shifting risk assessments and potential downstream market effects for healthcare institutions and life sciences companies, say attorneys at Arnall Golden.

• Series

  Playing Piano Makes Me A Better Lawyer

  

  Playing piano and practicing law share many parallels relating to managing complexity: Just as hearing an entire musical passage in my head allows me to reliably deliver the message, thinking about the audience's impression helps me create a legal narrative that keeps the reader engaged, says Michael Shepherd at Fish & Richardson.

• 3 Cases Highlight SEC Distinction Between Exec, Co. Liability

  

  Three recent enforcement actions against Spero Therapeutics, Lottery.com and Archer-Daniels-Midland demonstrate that while public companies are subject to liability for misrepresentations, the U.S. Securities and Exchange Commission is focused on individual liability when disclosure violations involve so-called half-truths, say attorneys at Cooley.

• AI-Generated Doc Ruling Guides Attys On Privilege Risks

  

  A New York federal court's ruling, in U.S. v. Heppner, that documents created by a defendant using an artificial intelligence tool were not privileged, can serve as a guide to attorneys for retaining attorney-client or work-product privilege over client documents created with AI, say attorneys at Sher Tremonte.

• The Law Firm Merger Diaries: Leadership Strategy After Day 1

  

  For law firm leaders, ensuring a newly combined law firm lives up to its promise, both in its first days of operation and well after, includes tough decisions, clear and specific communication, and cheerleading, says Peter Michaud at Ballard Spahr.

• Record FCA Recoveries Signal Intensified Healthcare Focus

  

  In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveries and government-initiated healthcare matters last year indicates robust enforcement ahead, though the administration's focus on current policy objectives also extends beyond the healthcare sector, say attorneys at Epstein Becker.

• Fed. Circ. In Jan.: On The Validity Of Expert Testimony

  

  The Federal Circuit's recent decision in Barry v. DePuy, addressing whether expert testimony is admissible even if it does not strictly adhere to the court's claim construction, suggests that exclusion via a Daubert motion is appropriate only when the line to improper testimony is clearly crossed, say attorneys at Knobbe Martens.