Expert Analysis

• 9th Circ. Scienter Ruling May Strengthen FDA's Leverage

  

  A recent Ninth Circuit decision in U.S. v. Marschall — regarding scienter and violations of the Federal Food Drug and Cosmetic Act — appears to give the U.S. Food and Drug Administration another arrow in its quiver to lob in the direction of any repeat offender, with potentially very broad applications, say Elena Quattrone and Zachary Taylor at Epstein Becker.

• In The World Of Legal Ethics, 10 Trends To Note From 2023

  

  Lucian Pera at Adams and Reese and Trisha Rich at Holland & Knight identify the top legal ethics trends from 2023 — including issues related to hot documents, artificial intelligence and cybersecurity — that lawyers should be aware of to put their best foot forward.

• Lessons Learned From 2023's Top ADA Decisions

  

  This year saw the courts delving into the complexities of employee accommodations under the Americans with Disabilities Act in the post-pandemic workplace, going beyond bright-line rules with fact-intensive inquiries that are likely to create uncertainty for employers, says Linda Dwoskin at Dechert.

• How Attorneys Can Be More Efficient This Holiday Season

  

  Attorneys should consider a few key tips to speed up their work during the holidays so they can join the festivities — from streamlining the document review process to creating similar folder structures, says Bennett Rawicki at Hilgers Graben.

• Top 10 Whistleblowing And Retaliation Events Of 2023

  

  The U.S. Securities and Exchange Commission and federal and state courts made 2023 another groundbreaking year for whistleblower litigation and retaliation developments, including the SEC’s massive whistleblower awards, which are likely to continue into 2024 and further incentivize individuals to submit tips, say attorneys at Proskauer.

• Series

  Children's Book Writing Makes Me A Better Lawyer

  

  Becoming a children's book author has opened doors to incredible new experiences of which I barely dared to dream, but the process has also changed my life by serving as a reminder that strong writing, networking and public speaking skills are hugely beneficial to a legal career, says Shaunna Bailey at Sheppard Mullin.

• New Pharma Guidelines Bring Pitfalls For Compounders

  

  New guidelines from U.S. Pharmacopeia, which went into effect last month, require some extensive and potentially expensive compliance efforts from hospitals and compounding pharmacies, and smaller compounders could particularly struggle, says Natalia Mazina at Mazina Law.

• The State Of CFPB Focus On Credit Reporting Of Medical Debt

  

  An increase in credit reporting complaints and the Consumer Financial Protection Bureau's recent annual report on the Fair Debt Collection Practices Act — which focuses on medical debt in credit reporting — are both evidence of the fact that the bureau will continue to prioritize oversight of credit reporting of medical debt, says Kristen Watson at Burr & Forman.

• Opinion

  What Happens If High Court Rejects Releases In Purdue Ch. 11

  

  Reading the tea leaves following the U.S. Supreme Court's recent arguments in Harrington v. Purdue Pharma, it appears likely that the justices will decide that bankruptcy courts lack the power to release third-party claims against nondebtors, which would result in one of three scenarios, says Gregory Germain at Syracuse University.

• FDA's Recent Litigation Records Are Strong, But Imperfect

  

  The U.S. Food and Drug Administration has notched its share of litigation wins in recent years thanks to a number of key advantages, but the FDA has been less successful in certain highly visible arenas, Jonathan Berman and Colleen Heisey at Jones Day.

• 5 Steps For Healthcare Companies After Biden's AI Order

  

  Rather than simply monitoring for the issuance of agency guidelines on artificial intelligence in the wake of President Joe Biden's October executive order, health and life sciences companies should take action now and begin building internal operational and technical infrastructures designed to govern the use of AI, says Joy Sharp at Faegre Drinker.

• Opinion

  Giving The Gov't Drug Patent March-In Authority Is Bad Policy

  

  The Biden administration's recent proposal to allow government seizure of certain taxpayer-funded drug patents is a terrible idea that would negate the benefits of government-funded research, to the detriment of patients and the wider economy, says Wayne Winegarden at Pacific Research Institute.

• How Clients May Use AI To Monitor Attorneys

  Excerpt from Practical Guidance

  

  Artificial intelligence tools will increasingly enable clients to monitor and evaluate their counsel’s activities, so attorneys must clearly define the terms of engagement and likewise take advantage of the efficiencies offered by AI, says Ronald Levine at Herrick Feinstein.

• When Patients Have Standing For Hospital Antitrust Suits

  

  Brown v. Hartford Healthcare Corp., recently decided by a Connecticut state court, provides a useful examination of how antitrust standing issues may be analyzed when patients directly sue a healthcare system for anti-competitive conduct, says Charles Honart at Stevens & Lee.

• How AI Executive Order Aims To Compete For Foreign Talent

  

  Immigration provisions within the Biden administration's executive order on artificial intelligence take a strategic approach to promoting the U.S. as a destination for AI and STEM talent by streamlining visa processing, enhancing educational and exchange programs, and improving current visa programs and pathways to permanent residency, says Eric Bord at Morgan Lewis.