Expert Analysis

• Key Takeaways As HRSA Aims To Revive 340B Rebate Pilot

  

  The U.S. Department of Health and Human Services' recent request for feedback on the 340B Rebate Model Pilot Program demonstrates that it intends to correct the model's procedural defects, which is positive news for participating manufacturers, but a setback for covered entities, say attorneys at Manatt.

• When MDLs Drag, State Courts Can Speed Mass Tort Results

  

  Understanding the structural dynamics that can delay resolution in multidistrict litigation is essential to understanding why a state court strategy is sometimes not merely attractive, but necessary for plaintiffs seeking timely and just outcomes, say attorneys at DiCello Levitt.

• Leveraging MDLs And State Courts In Mass Tort Strategy

  

  Multidistrict litigation's quiet drift from a pretrial coordination device to a de facto national court for mass torts poses a strategic question for plaintiffs counsel — whether an MDL will yield timely trials, meaningful accountability and fair value for clients, or whether a state court strategy will be more effective, say attorneys at DiCello Levitt.

• Unique Issues Facing Brand-Compounder Patent Litigation

  

  Recent litigation and potential enforcement action against Hims & Hers Health raise questions about how compounders and branded pharmaceuticals companies would be positioned in patent litigation as compared to generics companies, which would require strategies different from those that would be used in traditional Hatch-Waxman Act litigation, say attorneys at Morgan Lewis.

• Series

  Volunteering With Scouts Makes Me A Better Lawyer

  

  Serving as an assistant scoutmaster for my son’s troop reaffirmed several skills and principles crucial to lawyering — from the importance of disconnecting to the value of morality, says Michael Warren at McManis Faulkner.

• Series

  Law School's Missed Lessons: In Court, It's About Storytelling

  

  Law school provides doctrine, cases and hypotheticals, but when lawyers step into the courtroom, they must learn the importance of clarity, credibility, memorability and preparation — in other words, how to tell simple, effective stories, say Nicholas Steverson and Danielle Trujillo at Wheeler Trigg, and Lisa DeCaro at Courtroom Performance.

• 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.