Expert Analysis

• 10 Practical Takeaways From FDA's Biopharma AI Guidance

  

  Recent guidance from the U.S. Food and Drug Administration provides much-needed insight on the usage of artificial intelligence in producing information to support regulatory decision-making regarding drug safety, with implications ranging from life cycle maintenance to AI tool acquisition, say attorneys at Covington.

• What Rodney Hood's OCC Stint Could Mean For Banking

  

  Acting Comptroller of the Currency Rodney Hood's time at the helm of the OCC, while temporary, is likely to feature clarity for financial institutions navigating regulations, the development of fintech innovation, and clearer expectations for counsel advising on related matters, say attorneys at Vedder Price.

• Opinion

  We Must Allow Judges To Use Their Independent Judgment

  

  As two recent cases show, the ability of judges to access their independent judgment crucially enables courts to exercise the discretion needed to reach the right outcome based on the unique facts within the law, says John Siffert at Lankler Siffert & Wohl.

• 4 Actions For Cos. As SEC Rebrands Cyber Enforcement Units

  

  As the U.S. Securities and Exchange Commission signals its changing enforcement priorities by retooling a Biden-era crypto-asset and cybersecurity enforcement unit into a task force against artificial-intelligence-powered hacks and online investing fraud, financial institutions and technology companies should adapt by considering four key points, say attorneys at Troutman.

• The Central Issues Facing Fed. Circ. In Patent Damages Case

  

  The en banc Federal Circuit's pending review of EcoFactor v. Google could reshape how expert damages opinions are argued, and could have ripple effects that limit jury awards, say attorneys at McAndrews Held.

• How Health Cos. Can Navigate Data Security Regulation Limbo

  

  Despite the Trump administration's freeze on proposed updates to the Health Insurance Portability and Accountability Act security rule, there are critical cybersecurity steps healthcare organizations can take now without clear federal guidance, says William Li at Axiom.

• 4 Key Payments Trends For White Collar Attys

  

  As the payments landscape continues to innovate and the new administration looks to expand the role of digital currency in the American economy, white collar practitioners should be aware of several key issues in this space, say attorneys at Jenner & Block.

• Series

  Performing Stand-Up Comedy Makes Me A Better Lawyer

  

  Whether I’m delivering a punchline on stage or a closing argument in court, balancing stand-up comedy performances and my legal career has demonstrated that the keys to success in both endeavors include reading the room, landing the right timing and making an impact, says attorney Rebecca Palmer.

• 3 Del. Bankruptcy Cases Highlight US Trustee Objections

  

  As three recent Delaware bankruptcy cases show, debtors who seek approval of a stalking horse bid protections agreement should be prepared for the U.S. Trustee Office's objections, including if the proposed classification for the bid protections is a superpriority administrative expense claim, says Kyle Arendsen at Squire Patton.

• Series

  Adapting To Private Practice: From SEC To BigLaw

  

  As I adjusted to the multifaceted workflow of a BigLaw firm after leaving the U.S. Securities and Exchange Commission, working side by side with new colleagues on complex matters proved the fastest way to build a deep rapport and demonstrate my value, says Jennifer Lee at Jenner & Block.

• How Fed. Circ. Ruling Complicates Patent Infringement Cases

  

  The Federal Circuit's decision last month in Kroy IP Holdings v. Groupon may make defending patent infringement claims more challenging, time-consuming and expensive — but it has also complicated similar patent infringement proceedings involving the same patents and their appeals, say attorneys at Norton Rose.

• Making The Case For Rest In The Legal Profession

  

  For too long, a culture of overwork has plagued the legal profession, but research shows that attorneys need rest to perform optimally and sustainably, so legal organizations and individuals must implement strategies that allow for restoration, says Marissa Alert at MDA Wellness, Carol Ross-Burnett at CRB Global, and Denise Robinson at The Still Center.

• How Amended Rule 702 Affects Testimony In Patent Litigation

  

  In 2023, Federal Rule of Evidence 702 was amended to address the apparent failure of some courts to prevent unreliable expert evidence from reaching a jury, but a statistical analysis of Daubert decisions in 2022 and 2024 shows that courts remain divided about how to apply consistent evidence standards, say attorneys at Perkins Coie.

• 1st Circ. IMessage Ruling Illustrates Wire Fraud Circuit Split

  

  The First Circuit’s recent decision that text messages exchanged wholly within Massachusetts but transmitted by the internet count as interstate commerce spotlights a split in how circuits interpret intrastate actions under the federal wire fraud statute, perhaps prompting U.S. Supreme Court review, say attorneys at ArentFox Schiff.

• Opinion

  CPSC's Amazon Ruling Is A Win For Safety, Accountability

  

  A recent U.S. Consumer Product Safety Commission order classifying Amazon.com as a distributor, and requiring it to comply with notice, recall, refund and remediation obligations for defective products, is a major victory for consumer safety — and for attorneys pursuing product liability claims against major online retailers, says Donald Fountain at Clark Fountain.