Expert Analysis

• 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.

• Preparing For Broader Calif. Rules On PE Healthcare Deals

  

  California's recent emergency regulations implementing expanded healthcare transaction review requirements, such as for private equity and hedge funds, represent a notable expansion of state oversight, including enhanced disclosures, wider definitions and new advance notice requirements, say attorneys at Simpson Thacher.

• DOJ Policy Creates New Defense For Physicians, Health Cos.

  

  The U.S. Department of Justice's recently revised enforcement policy governing agency guidance makes clear that Medicare guidance is not the law, potentially giving healthcare organizations a stronger basis to challenge certain enforcement theories, says Jose Vela at Clark Hill.

• $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.

• 8th Circ. Ruling Raises Bar For Seeking Disability Benefits

  

  The Eighth Circuit's recent ruling in Post v. Bisignano signals that claimants seeking Social Security disability benefits may need to offer convincing proof of functional restrictions beyond their treating doctors' opinions and illustrates that the court's proclaimant jurisprudence no longer prevails, says Mark DeBofsky at DeBofsky Law.

• FCA Ruling May Open Door To Redacting Defendants' Names

  

  A recent Florida federal court decision may signal a shift from the long-prevailing view that False Claims Act defendants' identities must always be revealed when qui tam actions are unsealed, potentially providing important protection for healthcare fraud defendants who may face career consequences from unproven allegations, say attorneys at Holland & Knight.

• 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.

• Tracking Trends In State-Level Regulatory Enforcement

  

  State-level enforcement now increasingly involves antitrust, artificial intelligence and data privacy issues, and the key for organizations to reducing risk is having the ability to respond across governance, public affairs, discovery and remediation in multiple states simultaneously, say consultants at FTI Consulting.

• 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.

• How Cannabis Rescheduling Is Reshaping Bankruptcy

  

  As broader cannabis rescheduling awaits a recommended decision, cannabis companies continue to test the boundaries of the Bankruptcy Code, with the recent Cannabist Chapter 15 recognition order suggesting that governmental resistance may be reduced in future filings, say attorneys at Thompson Coburn.