Expert Analysis

• FDA's Hasty Policymaking Approach Faces APA Challenges

  

  Though the U.S. Food and Drug Administration has abandoned its usual notice-and-comment process for implementing new regulatory initiatives, two recent district court decisions make clear that these programs are still susceptible to Administrative Procedure Act challenges, says Rachel Turow at Skadden.

• The Metamorphosis Of The Major Questions Doctrine

  

  The so-called major questions doctrine arose as a counterweight to Chevron deference over the past few decades, but invocations of the doctrine have persisted in the year since Chevron was overturned, suggesting it still has a role to play in reining in agency overreach, say attorneys at Crowell & Moring.

• Compliance Lessons From 1st-Ever Product Safety Sentences

  

  A California federal judge’s recent sentencing of two former Gree USA executives in a landmark Consumer Product Safety Act case serves as a reminder of the federal government’s willingness to pursue criminal prosecution of individuals who fail to report safety hazards, as well as companies’ need to strengthen their reporting and compliance programs, say attorneys at Cooley.

• 9th Circ. Decisions Help Clarify Scope Of Legal Lab Marketing

  

  Two Ninth Circuit decisions last week provide a welcome development in clarifying the line between laboratories' legal marketing efforts and undue influence that violates the Eliminating Kickbacks in Recovery Act, and offer useful guidance for labs seeking to mitigate enforcement risk, says Joshua Robbins at Buchalter.

• Series

  Playing Mah-Jongg Makes Me A Better Mediator

  

  Mah-jongg rewards patience, pattern recognition, adaptability and keen observation, all skills that are invaluable to my role as a mediator, and to all mediating parties, says Marina Corodemus.

• Series

  Law School's Missed Lessons: Navigating Client Trauma

  

  Law schools don't train students to handle repeated exposure to clients' traumatic experiences, but for litigators practicing in areas like civil rights and personal injury, success depends on the ability to view cases clinically and to recognize when you may need to seek help, says Katie Bennett at Robins Kaplan.

• Challenging A Class Representative's Adequacy And Typicality

  

  Recent cases highlight that a named plaintiff cannot certify a putative class action unless they can meet all the applicable requirements of the Federal Rules of Civil Procedure, so defendants should consider challenging a plaintiff's ability to meet typicality and adequacy requirements early and often, say attorneys at Womble Bond.

• Opinion

  Juries Are Key In Protecting The Rule Of Law

  

  Absent from the recent discourse about U.S. rule of law is the crucial role of impartial jurors in protecting the equitable administration of justice, and attorneys and judges should take affirmative steps to reverse the yearslong decline of jury trials at this critical moment, says consultant Clint Townson.

• Opinion

  4 Former Justices Would Likely Frown On Litigation Funding

  

  As courts increasingly confront cases involving hidden litigation finance contracts, the jurisprudence of four former U.S. Supreme Court justices establishes a constitutional framework that risks erosion by undisclosed financial interests, says Roland Eisenhuth at the American Property Casualty Insurance Association.

• State Law Challenges In Enforcing Arbitration Clauses

  

  In recent cases, state courts in Pennsylvania, Massachusetts and New Jersey have considered or endorsed heightened standards for arbitration agreements, which can mean the difference between a bilateral arbitration and a full-blown class action in court, says Fabien Thayamballi at Shapiro Arato.

• How Attys Can Use AI To Surface Narratives In E-Discovery

  

  E-discovery has reached a turning point where document review is no longer just about procedural tasks like identifying relevance and redacting privilege — rather, generative artificial intelligence tools now allow attorneys to draw connections, extract meaning and tell a coherent story, says Rose Jones at Hilgers Graben.

• Series

  Playing The Violin Makes Me A Better Lawyer

  

  Playing violin in a string quartet reminds me that flexibility, ambition, strong listening skills, thoughtful leadership and intentional collaboration are all keys to a successful legal practice, says Julie Park at MoFo.

• Federal Regs Order May Spell Harsher FDCA Enforcement

  

  A recent executive order aimed at reducing criminal prosecutions of those who unknowingly violate complex federal regulations may actually lead to more aggressive felony indictments under the Federal Food, Drug and Cosmetic Act, but companies and executives can mitigate risks by following several key principals, say attorneys at McGuireWoods.

• Series

  Law School's Missed Lessons: Practicing Self-Care

  

  Law schools don’t teach the mental, physical and emotional health maintenance tools necessary to deal with the profession's many demands, but practicing self-care is an important key to success that can help to improve focus, manage stress and reduce burnout, says Rachel Leonard​​​​​​​ at MG+M.

• Forensic Challenges In Lithium-Ion Battery Fire Cases

  

  Lawsuits over lithium-ion battery fires and explosions often center on the core question of whether the battery was defective or combusted due to some other external factor — so both plaintiff and defense attorneys litigating these cases must understand the forensic issues involved, says Drew LaFramboise at Joseph Greenwald.