Expert Analysis

• 4 Pharma Industry Arguments Against CMS Drug Pricing Plan

  

  The Centers for Medicare & Medicaid Services is facing significant pushback regarding its plans for implementing the Inflation Reduction Act's Medicare drug price negotiation program, due to a number of potential repercussions for manufacturers, say attorneys at Mintz Levin.

• As AI Pricing Tools Evolve, So Does Antitrust Risk

  

  As the use of pricing algorithms has given rise to regulatory scrutiny and civil actions, such as RealPage Rental Software Antitrust Litigation in the Middle District of Tennessee and Gibson v. MGM in the District of Nevada, independent pricing decisions and other best practices can help limit antitrust risk, say attorneys at Axinn.

• Issues Ahead As Psychedelic Medicine Faces Pivotal Moment

  

  Recent regulatory changes and decriminalization efforts have opened doors for research and development in psychedelic medicine, but challenges like stigma, access and funding persist, meaning companies will need to address these issues to support the industry’s credibility, say consultants at FTI Consulting.

• Bracing For Regulatory Delays As Shutdown Looms

  

  As a government shutdown looms, stakeholders should plan for regulatory delays and note that more regulations could become vulnerable to congressional disapproval under the Congressional Review Act, say Matthew Shapanka and Holly Fechner at Covington.

• An Overview Of 6 PBM Bills Moving Through Congress

  

  As legislators turn to pharmacy benefit manager reform as a potential next step in addressing the cost of prescription drugs, six congressional committees have recently advanced PBM-related legislation with generally high bipartisan support, suggesting that a final package is likely to advance through Congress, say Rachel Stauffer and Katie Waldo at McDermott+Consulting.

• Exclusivity Loss Holds Power In Trade Secret Damages Claims

  

  A Pennsylvania federal court's recent decision in Elite Transit v. Cunningham adds to a growing body of case law that illustrates how the loss of trade secret exclusivity alone may be sufficient for claiming damages, even when commercialization of a trade secret has not occurred, say Christopher DeBaere and Julia Bloch at Archway Research.

• What Large Language Models Mean For Document Review

  

  Courts often subject parties using technology assisted review to greater scrutiny than parties conducting linear, manual document review, so parties using large language models for document review should expect even more attention, along with a corresponding need for quality control and validation, say attorneys at Sidley.

• Checking In On How SuperValu Has Altered FCA Litigation

  

  Four months after the U.S. Supreme Court's ruling in U.S. ex rel. Chutte v. SuperValu, the decision's reach may be more limited than initially anticipated, with the expansion of the scienter standard counterbalanced by some potential defense tools for defendants, say Elena Quattrone and Olivia Plinio at Epstein Becker.

• Future Paths For AI Inventorship After Justices' Thaler Denial

  

  Anup Iyer at Moore & Van Allen examines the current and future state of AI inventorship in the wake of the U.S. Supreme Court's decision not to hear Thaler v. Vidal, including collaboration, international challenges, and the need for closer examination in research and development-intensive sectors.

• Series

  Participating In Living History Makes Me A Better Lawyer

  

  My role as a baron in a living history group, and my work as volunteer corporate counsel for a book series fan association, has provided me several opportunities to practice in unexpected areas of law — opening doors to experiences that have nurtured invaluable personal and professional skills, says Matthew Parker at the Nebraska Department of Health and Human Services.

• How Attys Can Weather The Next Disaster Litigation Crisis

  

  On the heels of a number of damage catastrophes and ensuing litigation this summer alone, attorneys must recognize that it’s a matter of when, not if, the next disaster — whether natural or artificial — will strike, and formulate plans to minimize risks, including consolidating significant claims and taking remedial measures, says Mark Goldberg at Cosmich Simmons.

• Opinion

  Private Equity Owners Can Remedy Law Firms' Agency Issues

  

  Nonlawyer, private-equity ownership of law firms can benefit shareholders and others vulnerable to governance issues such as disparate interests, and can in turn help resolve agency problems, says Michael Di Gennaro at The Law Practice Exchange.

• Application Of Defend Trade Secrets Act Continues To Vary

  

  Seven years after the passage of the Defend Trade Secrets Act, anticipated uniformity has proved somewhat elusive, with federal courts sometimes incorporating state-law requirements into claims brought under the act instead of using it to bypass inconsistencies between state laws, say attorneys at MoloLamken.

• A Topic-Based Analysis Of FDA Responses To FOIA Requests

  

  By using a topic modeling method, it's possible to discern the major recurring topics in Freedom of Information Act requests made to the U.S. Food and Drug Administration, as well as the likelihood of success for individual topics, says Bradley Thompson at Epstein Becker.

• Opinion

  Proving Causation Is Key To Fairness And Justice

  

  Ongoing litigation over talc and acetaminophen highlights the important legal distinction between correlation and causation — and is a reminder that, while individuals should be compensated for injuries, blameless parties should be protected from unjust claims, say Drew Kershen at the University of Oklahoma College of Law, and Henry Miller at the American Council on Science and Health.