Expert Analysis

• Key Risks For Cos. As MAHA Influences Food Regulation

  

  As the Make America Healthy Again movement alters state and federal legislative and regulatory priorities, measures targeting ultra-processed foods, front-of-package labeling requirements and restrictions on schools are creating new compliance and litigation risks for food and beverage manufacturers, pharmaceutical companies, retailers and digital advertisers, say attorneys at Kelley Drye.

• State AGs May Extend Their Reach To Nat'l Security Concerns

  

  Companies with foreign supply-chain risk exposure need a comprehensive risk-management strategy to address a growing trend in which state attorneys general use broadly written state laws to target conduct that may not violate federal regulations, but arguably constitutes a national security threat, say attorneys at Wiley.

• Opinion

  Despite Deputy AG Remarks, DOJ Can't Sideline DC Bar

  

  Deputy Attorney General Todd Blanche’s recent suggestion that the D.C. Bar would be prevented from reviewing misconduct complaints about U.S. Department of Justice attorneys runs contrary to federal statutes, local rules and decades of case law, and sends the troubling message that federal prosecutors are subject to different rules, say attorneys at HWG.

• Unique Aspects Of Texas' Approach To AI Regulation

  

  The Texas Responsible AI Governance Act — which will soon be the sole comprehensive artificial intelligence law in the U.S. — pulls threads from EU and Colorado laws but introduces more targeted rules with fewer obligations on commercial entities, say attorneys at MVA Law.

• 3 Takeaways From FDA Cell And Gene Therapy Draft Guidance

  

  The U.S. Food and Drug Administration recently published draft guidance documents that sketch the clearest picture yet of the evolving regulatory framework for cell and gene therapies, reflecting an agency that is increasingly comfortable with flexible, science-driven approaches that extend beyond clinical trial models, say attorneys at MoFo.

• Rule Amendments Pave Path For A Privilege Claim 'Offensive'

  

  Litigators should consider leveraging forthcoming amendments to the Federal Rules of Civil Procedure, which will require early negotiations of privilege-related discovery claims, by taking an offensive posture toward privilege logs at the outset of discovery, says David Ben-Meir at Ben-Meir Law.

• IP Ownership Risk Grows In Booming Cancer Drug Market

  

  The ownership of intellectual property has become strategically decisive in deals involving valuable cancer therapeutics known as ADCs, as highlighted by the recent Takeda-Innovent deal, with the commercial value of a license resting on the integrity and defensibility of the underlying technology, say attorneys at Loeb & Loeb.

• Series

  My Miniature Livestock Farm Makes Me A Better Lawyer

  

  Raising miniature livestock on my farm, where I am fully present with the animals, is an almost meditative time that allows me to return to work invigorated, ready to juggle numerous responsibilities and motivated to tackle hard issues in new ways, says Ted Kobus at BakerHostetler.

• Surveying The Healthcare Policy Landscape Post-Shutdown

  

  With last week's agreement to reopen the federal government, at least through the end of January, key healthcare legislation that has been in limbo since a December 2024 spending bill fell apart may recapture the attention of Congress, say attorneys at Faegre Drinker.

• FDA Biosimilar Guidance Should Ease Biologics Development

  

  New draft guidance from the U.S. Food and Drug Administration, indicating that the agency may no longer routinely require comparative efficacy studies when other evidence provides sufficient assurance of biosimilarity, underscores the FDA's trust in analytical technology as a driver of biologics access, say attorneys at Hogan Lovells.

• Litigation Funding Could Create Ethics Issues For Attorneys

  

  A litigation investor’s recent complaint claiming a New York mass torts lawyer effectively ran a Ponzi scheme illustrates how litigation funding arrangements can subject attorneys to legal ethics dilemmas and potential liability, so engagement letters must have very clear terms, says Matthew Feinberg at Goldberg Segalla.

• E-Discovery Quarterly: Recent Rulings On Dynamic Databases

  

  Several recent federal court decisions illustrate how parties continue to grapple with the discovery of data in dynamic databases, so counsel involved in these disputes must consider how structured data should be produced consistent with the requirements of the Federal Rules of Civil Procedure, say attorneys at Sidley.

• Prison Body Cams Raise Health Privacy Compliance Issues

  

  The increasing use of prison staff body cameras to enhance transparency and safety presents correctional healthcare partners with new risk management questions where they must carefully reconcile the benefits of surveillance with the imperative to protect patient privacy, say attorneys at Gordon Rees.

• Series

  Building With Lego Makes Me A Better Lawyer

  

  Building with Lego has taught me to follow directions and adapt to unexpected challenges, and in pairing discipline with imagination, allows me to stay grounded while finding new ways to make complex deals come together, says Paul Levin at Venable.

• Series

  Law School's Missed Lessons: Networking 101

  

  Cultivating a network isn't part of the law school curriculum, but learning the soft skills needed to do so may be the key to establishing a solid professional reputation, nurturing client relationships and building business, says Sharon Crane at Practising Law Institute.