Expert Analysis

• Record FCA Recoveries Signal Intensified Healthcare Focus

  

  In its recently released False Claims Act statistics, the U.S. government's emphasis on record healthcare recoveries and government-initiated healthcare matters last year indicates robust enforcement ahead, though the administration's focus on current policy objectives also extends beyond the healthcare sector, say attorneys at Epstein Becker.

• Fed. Circ. In Jan.: On The Validity Of Expert Testimony

  

  The Federal Circuit's recent decision in Barry v. DePuy, addressing whether expert testimony is admissible even if it does not strictly adhere to the court's claim construction, suggests that exclusion via a Daubert motion is appropriate only when the line to improper testimony is clearly crossed, say attorneys at Knobbe Martens.

• Methods For Challenging State Civil Investigative Demands

  

  Ongoing challenges to enforcement actions underscore the uphill battle businesses face in arguing that a state investigation is prohibited by federal law, but when properly deployed, these arguments present a viable strategy to resist civil investigative demands issued by state attorneys general, say attorneys at Troutman Pepper.

• Calif.'s Civility Push Shows Why Professionalism Is Vital

  

  The California Bar’s campaign against discourteous behavior by attorneys, including a newly required annual civility oath, reflects a growing concern among states that professionalism in law needs shoring up — and recognizes that maintaining composure even when stressed is key to both succeeding professionally and maintaining faith in the legal system, says Lucy Wang at Hinshaw.

• A Potential Shift In FDA's Approach To Drug Trial Design

  

  Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

• Opinion

  SNAP Rule Confusion Risks A Compliance Crisis

  

  Recent Supplemental Nutrition Assistance Program food restriction waivers pose a compliance crisis for legal practitioners advising food retailers, amid higher costs and lack of a coherent national standard, says Tyson-Lord Gray at Yeshiva University’s Benjamin N. Cardozo School of Law.

• Series

  Trivia Competition Makes Me A Better Lawyer

  

  Playing trivia taught me to quickly absorb information and recognize when I've learned what I'm expected to know, training me in the crucial skills needed to be a good attorney, and reminding me to be gracious in defeat, says Jonah Knobler at Patterson Belknap.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• Opinion

  Federal Preemption In AI And Robotics Is Essential

  

  Federal preemption offers a unified front at a decisive moment that is essential for safeguarding America's economic edge in artificial intelligence and robotics against global rivals, harnessing trillions of dollars in potential, securing high-skilled jobs through human augmentation, and defending technological sovereignty, says Steven Weisburd at Shook Hardy.

• Series

  Law School's Missed Lessons: What Cross-Selling Truly Takes

  

  Early-career attorneys may struggle to introduce clients to practitioners in other specialties, but cross-selling becomes easier once they know why it’s vital to their first years of practice, which mistakes to avoid and how to anticipate clients' needs, say attorneys at Moses & Singer.

• How State FCA Activity May Affect Civil Fraud Enforcement

  

  A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.

• Wage-Based H-1B Rule Amplifies Lottery Risks For Law Firms

  

  Under the wage-based H-1B lottery rule taking effect Feb. 27, law firms planning to hire noncitizen law graduates awaiting bar admission should consider their options, as the work performed by such candidates may sit at the intersection of multiple occupational classifications with differing chances of success, says Jun Li at Reid & Wise.

• Series

  Judges On AI: Practical Use Cases In Chambers

  

  U.S. Magistrate Judge Allison Goddard in the Southern District of California discusses how she uses generative artificial intelligence tools in chambers to make work more efficient and effective — from editing jury instructions for clarity to summarizing key documents.

• Assessing Compliance Risks Around TrumpRx Participation

  

  As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.

• California's New Privacy Laws Demand Preparation From Cos.

  

  An increase in breach disclosures is coinciding with California's most comprehensive privacy and artificial intelligence legislation taking effect, illustrating the range of vulnerabilities organizations in the state face and highlighting that the key to successfully managing these requirements is investing in capabilities before they became urgent, says Camilo Artiga-Purcell at Kiteworks.