Expert Analysis

• New DNA Screening Standard Has No Clear Playbook

  

  Although the government has not yet released promised guidance intended to support its new standards for screening mail-order DNA, companies should not read this as a reprieve from the Oct. 13 compliance deadline because the delay shifts enforcement risk to statutes that need no new authority, including false statements, the False Claims Act and fraud, says Ashwin Ram at Buchalter.

• Series

  Mich. Banking Brief: All The Notable Legal Updates In Q3

  

  We are at an inflection point for Michigan financial services law, with a state Supreme Court decision recently overruling more than 25 years of precedent on the Michigan Consumer Protection Act, and pending legislation that could significantly shift the regulatory landscape, say attorneys and advisers at Dykema.

• Testing AI's Promise For Large-Scale Document Review

  

  Our document-review comparison of attorneys' responsiveness and issue coding decisions versus predictions generated by artificial intelligence across 1,600 documents suggests that these tools can offer a reasonable and reliable basis for improved discovery workflows, provided lawyers understand where guardrails are needed, say attorneys at Redgrave.

• AG Watch: Va. Vape Product Regulations Enter A New Phase

  

  Virginia's new vape enforcement framework carries important implications related to product eligibility and certification requirements for businesses operating in the marketplace, representing the culmination of several years of legislative action, regulatory development, litigation and interagency planning, says Chuck Slemp at Cozen O'Connor.

• Navigating A Key Inflection Point In Biosimilar Sector M&A

  

  As biosimilar mergers and acquisitions gain notice amid U.S. Food and Drug Administration reforms, a maturing patent framework and a looming patent cliff, companies diversifying into the higher-growth biologics space should align their regulatory, intellectual property and transactional strategies, say attorneys at Skadden.

• AI Meeting Recaps Pose New Discovery And Privilege Risks

  

  The New York City Bar Association’s recent ethics opinion, cautioning attorneys not to record nonclient conversations with artificial intelligence tools, reflects an emerging view that AI meeting recaps are now a distinct business record category, meaning counsel should set meeting-level controls and apply framework-level updates, says William Wright at Faegre Drinker.

• FDA Bill Shows Risk Of Inexact Statute Text, Post-Loper Bright

  

  A recent House bill to amend the Food and Drug Administration's drug preclusion framework reveals the increased importance of precision when drafting statutory rules in a post-Loper Bright landscape, as several minor errors in the text could lock in unintended results that will be difficult to repeal, say attorneys at Venable.

• $95M Nev. Case Provides Clues On Wound Care Enforcement

  

  Federal prosecutors’ recent U.S. v. Dubin indictment, charging a Nevada physician with healthcare fraud over an alleged $95 million Medicare billing scheme involving amniotic wound allografts, provides a clearer picture of an increasingly data-driven enforcement strategy that follows the entire wound care transaction, say attorneys at Bass Berry.

• Beware Daubert Pitfalls With Technical Experts In Patent Suits

  Recent decisions on Daubert motions in patent cases show that courts will exclude expert testimony that lacks a solid factual or methodological foundation, regardless of the expert's credentials — underscoring the importance of demonstrating reliability, say attorneys at Steptoe.

• 4 Tips On Expert Gatekeeping From J&J Talc Deal

  

  Johnson & Johnson's successful campaign to exclude plaintiff-side oncologist testimony about whether its talcum powder caused ovarian cancer, which prompted the recent resolution of 70,000 claims, offers lessons on how product liability defendants can reshape risk calculation by rigorously applying expert admissibility rules, say attorneys at Hollingsworth.

• Series

  Playing Bid Whist Makes Me A Better Lawyer

  

  As a child, I viewed bid whist as a family tradition and a source of friendly card game competition, but as a lawyer, I see it as a tool that has helped me cultivate skills like communication, teamwork, risk assessment and composure, says Keyonn Pope at Riley Safer.

• Teva, Wyeth Show How Claimed Advances Shape Enablement

  

  Two recent Federal Circuit decisions involving method-of-treatment claims — Teva v. Eli Lilly and Wyeth v. AstraZeneca — reached opposite enablement outcomes from strikingly similar procedural postures, but a closer comparison of the cases reveals a three-step framework for understanding the court's reasoning, says Kendall Gurule at Polsinelli.

• Opinion

  Calif. Bill Goes Too Far In Trying To Regulate Attorney AI Use

  

  California’s first-in-the-nation act regulating how attorneys and arbitrators use generative artificial intelligence will likely soon become law, but read broadly, the provisions may dissuade lawyers from employing AI at all, thereby depriving them of key work tools, says Joshua Wurtzel at Schlam Stone.

• AI Rise In Healthcare Demands New Cybersecurity Strategies

  

  As artificial intelligence-related capabilities are increasingly integrated into medical devices and healthcare operations, organizations must adapt their compliance playbook to address evolving cybersecurity needs and implement lifecycle-based risk assessment approaches, say attorneys at Covington.

• Hims & Hers Suit Spotlights Health Data-Sharing Privacy Risks

  

  Regulators' complaint against telehealth company Hims & Hers alleging deceptive practices serves as a reminder that the privacy principles developed under consumer protection laws and predating omnibus statutes remain in force, and sensitive data governance continues to be a crucial component of compliance, say attorneys at Venable.