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.

• Key Strategies For Supplement Cos. Facing Lead Risks

  

  In the wake of a recent Consumer Reports article detailing dangerously high levels of lead in many popular protein powders, supplement companies face increased litigation, rising enforcement risks and reputational harm — underscoring the need to monitor supply chains, test ingredients and understand labeling standards, say attorneys at Husch Blackwell.

• From Bank Loans To Private Credit: Tips For Making The Shift

  

  The relationship between private credit and syndicated bank deals will evolve as the private market continues to grow, introducing new challenges for borrowers comparing financing options, particularly pertaining to loan documentation and working capital, say attorneys at Haynes Boone.

• 3 Takeaways From FDA Cell And Gene Therapy Draft Guidance

  

  The U.S. Food and Drug Administration recently published draft guidance documents that sketch the clearest picture yet of the evolving regulatory framework for cell and gene therapies, reflecting an agency that is increasingly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.

• How Cos. Should Prepare For Prop 65 Listing Of Bisphenols

  

  California regulators are moving toward classifying all p,p'-bisphenol chemicals as causing reproductive toxicity under Proposition 65, which could require warning notices for a vast range of consumer and industrial products, and open the floodgates to private litigation — so companies should proactively review their suppy chains, says Gregory Berlin at Alston & Bird.

• 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.

• How Litigating Antitrust Fix Helped GTCR Prevail In Court

  

  An Illinois federal judge's recent denial of the Federal Trade Commission's injunction request in the GTCR acquisition of Surmodics joins a developing series of cases in which deal parties have prevailed against government antitrust challenges by proposing a post-complaint fix and litigating the as-amended deal, say attorneys at Paul Weiss.